170e767b-0339-4ecd-b265-b6b5379ae96aUpdatePublished72021-02-052015-10-19In Commercial Distribution05037881106250PrimaryGS1Gelweave™7326108873261088229053087VASCUTEK LTD1Gelweave Gelatin Impregnated Woven Vascular Prosthesis 3 BRANCH PLEXUSfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)888-3786tmccustomer.admin@terumomedical.comK090987000K16279400035281Synthetic 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 DiameterDevice Size Text, specifyBranch length 15/15/15 cmDevice Size Text, specifyBranch diameter 10/8/8 mmSpecial 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