156af9d4-3a24-4fd2-9d12-e38e8baed845UpdatePublished62023-09-072016-08-09In Commercial Distribution04046964348662PrimaryGS104046964348648Unit of UseGS1Elite HV®612908612908784259751B BRAUN INTERVENTIONAL SYSTEMS, INC106FR X 12CM X .038 HEMO PT INTRODUCER SETfalsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK04352500058865Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.falseActiveDYBINTRODUCER, CATHETERSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyStore at room temptruefalse