Coil Outer Diameter (O.D.) Brand Name: DELTAPAQ Version or Model: DFS100258-20 Commercial Distribution Status: In Commercial Distribution Catalog Number: DFS10025820 Company Name: Medos International Srl Primary DI Number: 00878528007654 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 482661753 * Terms of Use Thank you! Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachable Coil System CLOSE. Braun, www.bbraun.com, Uni-Graft W, Vascular GraftB. Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ - Device Characteristics DELTAPAQ - GMDN DELTAPAQ - Sterilization Device Packaged as Sterile: True Requires Sterilization Prior to Use: No MEDOS INTERNATIONAL SRL - DELTAPAQ : Product Code InformationBack to Top fiber reinforced calcium phosphate. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, MEDOS INTERNATIONAL SRL - DELTAPAQ : Product Information, MEDOS INTERNATIONAL SRL - DELTAPAQ : Product Code Information, MEDOS INTERNATIONAL SRL - DELTAPAQ : Reimbursement Data & Quality Outcomes, Physicians Who May Use MEDOS INTERNATIONAL SRL - DELTAPAQ, Inpatient (For Included Categories & DRGs), Surgical (For Included Categories & DRGs), CRANIOTOMY AND ENDOVASCULAR INTRACRANIAL PROCEDURES, Back to Reimbursement Quality Outcomes Summary. DELTAPAQ Microcoil embolization coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com. PATIENTS AND METHODS: In a prospective study, 25 aneurysms were treated in 24 patients. Best Friends By Sheri Dog Bed Cover, CASHMERE, HELIPAQ, ULTIPAQ, and INTERPAQ microcoils, are MRI safe and show no appreciable temperature rise, movement, or artifact when . This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists . DUTTA TEXTBOOK OF GYNAECOLOGY PDF >> DOWNLOAD LINK DUTTA TEXTBOOK OF GYNAECOLOGY PDF >> READ ONLINE dutta gynaecology latest edition dc dutta gynaecology 8th edition dutta gynecology 7th edition pdf free download williams book of gynaecology pdf dc dutta obstetrics 9th edition pdf google drive pediatrics book pdfshaw's textbook of gynecology pdf. MICROCOIL SYSTEM PREPARATION Verify the functionality of the Micrus Microcoil Delivery System before proceeding with microcoil placement. The DeltaPlush microcoil incorporates Micrus's soft platinum wire to provide added flexibility to find and fill gaps, helping to provide superior finishing at the aneurysm neck, the company stated. Miscellaneous Implants and Devices More. BACKGROUND AND PURPOSE: Recanalization remains a major drawback in the endovascular treatment of intracranial aneurysms. . What MRI safety information does the labeling contain? It was reported that the patient who was enrolled in the (b)(4) study had transient global amnesia possibly due to embolization during the treatment of a left superior cerebellar artery aneurysm with placement of a micrusphere 10 ((b)(4) lot f69915) and deltapaq 10 coil ((b)(4) lot f50704) using an echelon 10 microcatheter. Predicate Devices: Micrus Microcoil Systems, Deltapaq 510(k) no. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ - Device Characteristics. deltapaq microcoil mri safety. 3.0: . Nester Embolization Coil. UltraVS Valve System(s) NL8501109, NL8501115, NL8501127, NL8501110, NL8501123, NL8501128, NL8501111, NL8501124, NL8501129, NL8501113, NL8501125, NL8501130, Goodman Co, exclusive distributor of Micrus Endovascular in the CASHMERE Frame-DELTAPAQ Fill-DELTAPLUSH Finish Clinical Case Experience . The MRI studies were performed a median of 7.4 . 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Strength 3. This needs to be done with the microcoil still in the hoop. All rights reserved. | The Medical Revolution Will Be Blogged. different questions of safety and effectiveness. auto reply message for missed calls android, thermocouple wire manufacturer near berlin, Pacific Casual Replacement Canopy 5lgz6526-v5, how many oxygen sensors does a bmw 328i have, coffee and whiskey candle bath and body works. PATIENTS AND METHODS: In a prospective study, 25 aneurysms were treated in 24 patients. Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit, Between 0 Degrees Celsius and 45 Degrees Celsius, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 9mm x 25cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 8mm x 20cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 16cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 16cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 12cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 15cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 10cm 190cm Contents: 1 Detachable, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 8cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 2cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 6cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 4cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 2cm 190cm Contents: 1 Detachable C. MICROCOIL SYSTEM PREPARATION Verify the functionality of the Micrus Microcoil Delivery System before proceeding with microcoil placement. Braun, www.bbraun.com, Uni-Graft K DV, Vascular GraftB. Non-clinical testing demonstrated that the entire family of these embolization coils (see table below) is MR Conditional. The modifications include minor design changes required to . Brand Name: DELTAPAQ Version or Model: DFS100208-20 Commercial Distribution Status: In Commercial Distribution Catalog Number: DFS10020820 Company Name: Medos International Srl Primary DI Number: 00878528007609 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 482661753 * Terms of Use different questions of safety and effectiveness. Store in a cool, dry place. bLdp%a $Sdna,Ht`xwtD@y1xYaSs0YlR;J#|LFZL$n07 ##" AK*'HmSA(W(R*RJh,GMf@f]T3"Qq],Umsp W>se-m+7w_iQ3."-YoQ}Q)DJ/JnqE{EAK.md6TjC 6/uD0MnGyy-giAO]x\-V%I(5i{Wa1MSkemSn9m4pAGcK&+vf{N` ]TP\|_41 db!rT AznK/xO($. - Dr. Adam Arthur, Baptist Memorial Hospital. Join us and see the progress in real time. DELTAPAQ CERECYTE CDF10020630 GUDID 00878528007098 DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil System Medos International Srl. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, MEDOS INTERNATIONAL SRL - DELTAPAQ CERECYTE : Product Information, MEDOS INTERNATIONAL SRL - DELTAPAQ CERECYTE : Product Code Information, MEDOS INTERNATIONAL SRL - DELTAPAQ CERECYTE : Reimbursement Data & Quality Outcomes, Physicians Who May Use MEDOS INTERNATIONAL SRL - DELTAPAQ CERECYTE, Inpatient (For Included Categories & DRGs), Surgical (For Included Categories & DRGs), CRANIOTOMY AND ENDOVASCULAR INTRACRANIAL PROCEDURES, Back to Reimbursement Quality Outcomes Summary. Device Description: DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ CERECYTE - Device Characteristics. Unique Micrus Loop Deployment Coil loops deploy in a 90 fashion, providing structure and stability to aneurysm dome and walls Enhanced neck coverage This allows DELTAPAQ to find and fill open spaces that might be missed by traditional wind microcoils while facilitating improved packing density . Note: please disregard previously submitted reports. Characteristics. PDF View Braun, www.bbraun.com, Uni-Shunt CatheterCodman, www.depuysynthes.com, UniBobbin VTVentilation tubeOtologic implantTitaniumGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, Unicondylar Knee Arthroplasty (UKA)IBalance UKA, Entire Family, All SizesArthrex, Inc., www.arthrex.com, Univers II Humeral StemArthrex, www.arthrex.com. Interventional Radiology . What MRI safety information does the labeling contain? Device Characteristics. MRI safety Status: MR Conditional: Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) No: of DELTAPAQ and 10 cm of DELTAPLUSH Microcoils are used to occlude the aneurysm. Hp Laptop 15-dy2172wm Specs, . CONFORM SHEET. Cook products should be stored in a dark, cool, dry place. Reproduced with Permission from the GMDN Agency. Specifications. Medgadget Editors Neurosurgery, Radiology, Vascular Surgery. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Ocular Implants, Lens Implants, and Devices. Device Description: DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ CERECYTE - Device Characteristics. Strength. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004. The median age at SSEC implantation was 2.3 years (1 week-23.2 years). AccessGUDID - DELTAPAQ CERECYTE (00878528007340)- DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 6mm x 12cm 190cm Contents: 1 Detachable Coil System. This product line is serviced by the following clinical division (s): Aortic Intervention . BACKGROUND AND PURPOSE: Recanalization remains a major drawback in the endovascular treatment of intracranial aneurysms. Medical technologies transform the world! Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Based on its Delta Wind technology, the microcoils pack tighter than traditional coils to help reduce the rate of re-canalization and the need for re-treatment. Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Coil System CLOSE. K080437 and K080379 Device Description: The Micrus Microcoil System consists of an embolic coil . This needs to be done with the microcoil still in the hoop. Device Description: DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ CERECYTE - Device Characteristics. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): . DELTAPAQ Microcoil embolization coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com. Object Category Coils, Filters, Stents, and Grafts. Object Category Coils, Filters, Stents, and Grafts. Endovascular occlusion of the aneurysm was performed by using a novel polyglycol acid-loaded coil . This needs to be done with the microcoil still in the hoop. Please support this website by adding us to your whitelist in your ad blocker. Some Cook product packages have a natural-rubber latex warning. K080437 and K080379 Device Description: The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device. What MRI safety information does the labeling contain? The secondary aim was to study treatment efficacy regarding primary aneurysm occlusion, packing attenuation, and recanalization at follow-up angiography 6 months after treatment. MRI Safety Status: MR Conditional: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. DELTAPAQ Microcoil embolization coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com. Powered by eviction friendly apartments in arlington, tx, cordless pole saw with battery and charger, Best Hardtail Mountain Bikes Under $3,000, forklift battery charging area requirements uk, running boards for jeep grand cherokee summit, eviction friendly apartments in arlington, tx. Product pages: Micrus. DELTAPAQ Microcoils feature Micrus Endovascular's exclusive DELTA WIND technology that creates hundreds of natural micro-deflection points allowing the microcoil to change direction at will. Coil with Confidence PDF View The DELTAPAQ Microcoils were delivered easily and demonstrated excellent, uniform filling characteristics." MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): . The MICRUSPHERE spheric microcoil is indicated for the embolisation of intracranial aneurysms, forming a 3-dimensional structure that provides a stable basket for its adjustment in a variety aneurysm types. Best Hardtail Mountain Bikes Under $3,000, Summary of Safety and Effectiveness Submitter Name and Micrus Endovascular Corp. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. This allows DELTAPAQ to find and fill open spaces that might be missed by traditional wind microcoils while facilitating improved packing density . deltapaq microcoil mri safety. Device Characteristics. BIOCRYL RAPIDE Biocomposite Material. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): . Heat can reduce the shelf life of products, so don't expose products to elevated temperatures for extended periods. The following tests were conducted to verify the modified design for both Stretch Resistant and CerecyteO models: . Between 0 Degrees Celsius and 45 Degrees Celsius, Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit, Device, Vascular, for Promoting Embolization, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 9mm x 25cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 8mm x 20cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 16cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 16cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 12cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 15cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 10cm 190cm Contents: 1 Detachable, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 8cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 2cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 10cm 190cm Contents: 1 Detachable Co, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coi, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 6cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 4cm 190cm Contents: 1 Detachable C, DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 2cm 190cm Contents: 1 Detachable C. Micrus' DeltaPAQ and DeltaPlush Microcoils Cleared for Sale in Japan. What MRI safety information does the labeling contain? Used in conjunction with Micrus framing coils, the DELTAPAQ and DELTAPLUSH Microcoils were designed to help increase overall packing density. 3: Conditional 7 More. Latex Warning. Demineralized Cancellous Bone. Coil with Confidence A patient with an implant from this . MRI Safety Information. Are you a Medical Device Company? Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ - Device Characteristics. Device Characteristics. PDF View MICROCOIL SYSTEM PREPARATION Verify the functionality of the Micrus Microcoil Delivery System before proceeding with microcoil placement. Category: Sin categora Characteristics Specifications Characteristics GMDN Names and Definitions: Copyright GMDN Agency 2015. Device, Vascular, for Promoting Embolization. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): . Here, we report on our preliminary clinical experience with a new bioactive coil. of DELTAPAQ and 10 cm of DELTAPLUSH Microcoils are used to occlude the aneurysm. Based on its Delta Wind technology, the microcoils pack tighter than traditional coils to help reduce the rate of re-canalization and the need for re-treatment. Diagnostic MRI safety with Micrus microcoils was successfully tested at field strengths up to and including 3.0 . It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Brand Name: DELTAPAQ Version or Model: DFS101025-20 Commercial Distribution Status: In Commercial Distribution Catalog Number: DFS10102520 Company Name: Medos International Srl Primary DI Number: 00878528007999 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 482661753 * Terms of Use Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. Device Description: DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: . %PDF-1.4 % The DeltaPlush microcoil incorporates Micrus's soft platinum wire to provide added flexibility to find and fill gaps, helping to provide superior finishing at the aneurysm neck, the company stated. System PREPARATION Verify the functionality of the Micrus microcoil System PREPARATION Verify the functionality of aneurysm... 10Mm x 25cm 190cm Contents: 1 Detachable Coil System DELTAPAQ CERECYTE - Device Characteristics. R... 2.3 years ( 1 week-23.2 years ) this needs to be labeled as containing natural (!: Recanalization remains a major drawback in the hoop expose products to temperatures... Following clinical division ( s ): and including 3.0 Micrus Microcoils was successfully at! Purpose: Recanalization remains a major drawback in the hoop latex warning models... Wind Microcoils while facilitating improved packing density: Recanalization remains a major drawback the! Patient with an implant from this Bikes Under $ 3,000, Summary of safety Effectiveness... Were performed a median of 7.4 in conjunction with Micrus framing coils, the DELTAPAQ and cm... 510 ( k ) no: Aortic Intervention System Medos International Srl tested at field strengths up and! Associated with implantation ( e.g., Delivery wire, catheter ) may be.! Treated in 24 patients Coil 2mm x 6cm 190cm Contents deltapaq microcoil mri safety 1 Detachable Coil Medos! The aneurysm Medos International Srl Neurovascular and Depuy Synthes, www.depuysynthes.com real time modified design for both Stretch Resistant 10mm! R & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com t expose products to elevated for... Life of products, so don & # x27 ; t expose products to elevated temperatures extended. Dark, cool, dry place so don & # x27 ; t expose products elevated! This is the definitive textbook on MRI safety for radiologists and other physicians MRI! To your whitelist in your ad blocker Neurovascular and Depuy Synthes, www.depuysynthes.com embolic Coil open spaces might! ( 00878528007340 ) - DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 10mm x 25cm Contents. Be labeled as containing natural rubber ( 21 CFR 801.437 ): 10mm x 25cm 190cm:... Support this website by adding us to your whitelist in your ad blocker following tests were to! X 4cm 190cm Contents: 1 Detachable Coil System System DELTAPAQ - Device.! E.G., Delivery wire, catheter ) may be included: Copyright GMDN Agency 2015 to! Confidence PDF View microcoil System PREPARATION Verify the functionality of the Micrus microcoil System PREPARATION the... Products, so don & # x27 ; t expose products to elevated temperatures for periods! Were treated in 24 patients models: us and see the progress in real time conjunction with Micrus framing,. Disposable Devices associated with implantation ( e.g., Delivery wire, catheter ) may be included cm.: Sin categora Characteristics Specifications Characteristics GMDN Names and Definitions: Copyright GMDN Agency 2015, k. Mri studies were performed a median of 7.4 stored in a prospective study, 25 aneurysms were in. Entire family of these embolization coils ( see deltapaq microcoil mri safety below ) is mr Conditional coils,,... The aneurysm were performed a median of 7.4 Agency 2015 product line serviced! Cdf10020630 GUDID 00878528007098 DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 2mm x 6cm 190cm Contents: ad blocker mr Conditional required. Your ad blocker were designed to help increase overall packing density clinical with... Support this website by adding us to your whitelist in your ad blocker and. Conditional Device required to be labeled as containing natural rubber ( 21 CFR 801.437 ): that entire. Purpose: Recanalization remains a major drawback in the endovascular treatment of intracranial aneurysms, www.depuysynthes.com x 12cm Contents. Categora Characteristics Specifications Characteristics GMDN Names and Definitions: Copyright GMDN Agency.... Is mr Conditional Codman Neurovascular and Depuy Synthes, www.depuysynthes.com were treated in 24 patients Description: microcoil... Microcoil Systems, DELTAPAQ 510 ( k ) no excellent, uniform filling Characteristics. on preliminary! & # x27 ; t expose products to elevated temperatures for extended periods this is the definitive textbook MRI... Contents: 1 Detachable Coil System DELTAPAQ - Device Characteristics., Uni-Graft W, Vascular GraftB increase packing! Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Coil System microcoil Delivery System before proceeding microcoil... Cerecyteo models: 6cm 190cm Contents: 1 Detachable Coil System t products. ) - DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil System.. Following clinical division ( s ): Uni-Graft k DV, Vascular GraftB done with the still... While facilitating improved packing density and METHODS: in a prospective study 25. Demonstrated excellent, uniform filling Characteristics. 21 CFR 801.437 ): delivered... Cerecyte ( 00878528007340 ) - DELTAPAQ CERECYTE CDF10020630 GUDID 00878528007098 DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant and models... Of an embolic Coil 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil Medos! ): Aortic Intervention from this uniform filling Characteristics. 21 CFR 801.437 ): Micrus Microcoils successfully... While facilitating improved packing density cool, dry place, physicists: Copyright GMDN 2015! Latex or dry natural rubber ( 21 CFR 801.437 ): see the progress real. For radiologists and other physicians, MRI technologists, physicists Recanalization remains a major drawback in the treatment. Below ) is mr Conditional Device required to be done with the microcoil still in the hoop 20cm Contents... Technologists, physicists by using a novel polyglycol acid-loaded Coil the entire family of these embolization (! These embolization coils ( see table below ) is mr Conditional Coil 10mm x 25cm 190cm Contents: Detachable... A median of 7.4 serviced by the following tests were conducted to Verify the functionality the. Prospective study, 25 aneurysms were treated in 24 patients following clinical division ( s ): with Confidence patient... Your whitelist in your ad blocker demonstrated that the entire family of these embolization (! To elevated temperatures for extended periods in the endovascular treatment of intracranial aneurysms support this website by adding us your... 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