531f108e-fda8-4296-aa02-4212a3af2027UpdatePublished42025-03-032016-09-242017-09-11Not in Commercial Distribution00827002251663PrimaryGS1Tri-ExG25166TXR-12-A079720472COOK INCORPORATED1Tri-Ex Extraction BalloonfalsefalsefalsefalsefalsetruetruefalsetruetruefalsetruefalseLabeling does not contain MRI Safety Informationtruefalse+1(812)330-5494sharedservices@cookmedical.comK95395100046715ERCP catheter, balloon, non-electrical, stone-retrievalA flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.falseActiveGCACATHETER, BILIARY, SURGICALSpecial Storage Condition, SpecifyStore in dark, dry, cool place.truefalse