ab3c1e64-4d70-4cc7-9319-416438b627f1UpdatePublished22021-02-052020-07-16In Commercial Distribution05037881010663PrimaryGS1Gelsoft™ Cardiovascular Patch961001S961001S229053087VASCUTEK LTD1Gelsoft Gelatin Impregnated Knitted Cardiovascular PatchfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)888-3786tmccustomer.admin@terumomedical.comK200955000K96361100035273Cardiovascular 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, specifyDimensions 10 x 1 cmSpecial Storage Condition, SpecifyStore in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.truefalse