594dd592-7b46-4842-a239-ce14f92287a1UpdatePublished62021-02-052015-10-222019-11-30Not in Commercial Distribution05037881011080PrimaryGS1Flouropassiv™920611FT920611FT229053087VASCUTEK LTD1Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCHfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)262-3304xx@xx.xx35273Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.trueActiveDXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEDevice Size Text, specifyDimension 6 x 110 mmSpecial Storage Condition, SpecifyStore in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.truefalse