c3abf597-4c7c-4995-9c27-f991a40b5a9fUpdatePublished72021-02-052015-10-19In Commercial Distribution05037881115504PrimaryGS1Gelsoft Plus™631206P631206P229053087VASCUTEK LTD1Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATEfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)888-3786tmccustomer.admin@terumomedical.comK162803000K95523000035281Synthetic 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 6 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