33b22e18-58e6-424d-b37b-4b6f672caabaUpdatePublished72021-02-052015-10-19In Commercial Distribution05037881110752PrimaryGS1Gelsoft™690807A690807A229053087VASCUTEK LTD1Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCEDfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)888-3786tmccustomer.admin@terumomedical.comK00200700035281Synthetic 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 diameter 7 mmDevice Size Text, specifyBranch length 40 cmSpecial 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