0f02bce2-c231-4134-aebe-71c5150f0fb5UpdatePublished62021-02-052015-10-192019-03-30Not in Commercial Distribution05037881141350PrimaryGS1SealPTFE™T7008EST7008ES229053087VASCUTEK LTD1SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis UltrathinfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)262-3304xx@xx.xx35281Synthetic vascular graftAn implantable 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.trueActiveDSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETERLengthLumen/Inner DiameterSpecial Storage Condition, SpecifyStore in clean, dry area at room temperature. Do not expose ePTFE products to temperature
greater than 500°F (260 °C).truefalse