Home GUDID 05037881151625 MAXIFLO™
Primary DI 05037881151625
Brand MAXIFLO™
Company VASCUTEK LTD
Model S2007P
Catalog number S2007P
Device description MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT. Wrap
Published 2017-07-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DSY PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05037881151625 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05037881151625 05037881151625 5037881151625
GMDN Terms# Term, Definition table Term Definition Synthetic vascular graft A sterile artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.
Device Sizes# Type, Value, Unit table Type Value Unit Length 20 Centimeter Lumen/Inner Diameter 7 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Regulatory Flags# DUNS number 229053087 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05037881184883 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881184890 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881184906 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881184913 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881184920 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881184937 Gelweave Vascular Prostheses 73241288/10QRME 73241288/10QRME 2026-05-22 05037881031712 Thoraflex™ Hybrid THP2224X100B THP2224X100B 2025-09-04 05037881031729 Thoraflex™ Hybrid THP2426X100B THP2426X100B 2025-09-04 05037881031736 Thoraflex™ Hybrid THP2628X100B THP2628X100B 2025-09-04 05037881031743 Thoraflex™ Hybrid THP2830X100B THP2830X100B 2025-09-04 05037881031750 Thoraflex™ Hybrid THP3032X100B THP3032X100B 2025-09-04 05037881031767 Thoraflex™ Hybrid THP3034X100B THP3034X100B 2025-09-04 05037881031774 Thoraflex™ Hybrid THP3036X100B THP3036X100B 2025-09-04 05037881031781 Thoraflex™ Hybrid THP3038X100B THP3038X100B 2025-09-04 05037881031798 Thoraflex™ Hybrid THP3040X100B THP3040X100B 2025-09-04 05037881031804 Thoraflex™ Hybrid THP3240X100B THP3240X100B 2025-09-04 05037881031811 Thoraflex™ Hybrid THP2224X150B THP2224X150B 2025-09-04 05037881031828 Thoraflex™ Hybrid THP2426X150B THP2426X150B 2025-09-04 05037881031835 Thoraflex™ Hybrid THP2628X150B THP2628X150B 2025-09-04 05037881031842 Thoraflex™ Hybrid THP2830X150B THP2830X150B 2025-09-04
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