27565c51-0165-402d-8235-f9efcec9cbc4UpdatePublished72023-09-072016-09-23In Commercial Distribution04046964555091PrimaryGS1Z-MED™611652611652784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1SO067 Z-MED 18X2X120falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK122012000K99197700017184Peripheral 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, transluminalOZTBalloon aortic valvuloplastyDevice Size Text, specifyLength : 20.000 MMDevice Size Text, specifyDiameter (mm) : 18.000 MMSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyStore at room tempSpecial Storage Condition, SpecifyStore in a dark placeSpecial Storage Condition, SpecifyStore in a dry placetruefalse