524cae1a-6720-4017-9c27-dcd91ee452bdUpdatePublished82023-09-072016-08-09In Commercial Distribution04046964337710PrimaryGS1Z-MED II™611768611768784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1PDZ668 ZMED II 25X3X100falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK003052000K12201200017453Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.falseActiveOZTBalloon aortic valvuloplastyDQYCATHETER, PERCUTANEOUSLITCatheter, angioplasty, peripheral, transluminalSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, SpecifyStore at room temptruefalse