3bdd7dc6-b008-45f3-a84d-fac8b720e0e9UpdatePublished32025-12-252024-12-04In Commercial Distribution00818136020768PackageGS1008181360202491In Commercial DistributionOuter/ Shipper Box00818136020249PrimaryGS1exGraftRGX181501RUX181501078340058PECA LABS, INC.118mm ID x 15cm L exGraft ePTFE Vascular GraftfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueMR ConditionaltruefalseK18361300035281Synthetic vascular graft, non-medicatedAn implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).trueActiveDSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterLumen/Inner DiameterLengthtruefalse