2b1543a6-e2f4-4773-8a11-43e9f512c484UpdatePublished62021-02-052015-10-19In Commercial Distribution05037881105826PrimaryGS1Gelweave™731809731809229053087VASCUTEK LTD1Gelweave Gelatin Impregnated Woven Vascular Prosthesis BIFURCATEfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)888-3786tmccustomer.admin@terumomedical.comK162794000K96466500035281Synthetic 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 DIAMETERLumen/Inner DiameterDevice Size Text, specifyBranch diameter 9 mmLengthSpecial Storage Condition, SpecifyStore in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.truefalse