96a00f8a-9b9b-4959-b8f3-28cde4ffbd3eUpdatePublished72023-09-072016-08-09In Commercial Distribution04046964291135PrimaryGS1Impactâ„¢164750164750784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1IMPACT 16MMX4CM75CMfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.com17184Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.falseActiveLITCatheter, angioplasty, peripheral, transluminalKNQDilator, esophagealSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, SpecifyStore at room temptruefalse