c94f427d-4fe7-420f-b9d3-d4695844182dUpdatePublished52024-12-232016-09-242018-10-28Not in Commercial Distribution10607915111660PackageGS10060791511166312018-10-28Not in Commercial Distribution00607915111663PrimaryGS1Acucise® Endopyelotomy SystemB1005187129135APPLIED MEDICAL RESOURCES CORPORATION1Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIREfalsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1.949.713.8300contact@appliedmedical.com46691Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.falseActive35511Vascular catheter flush valve, continuousA specialized, sterile, Y-piece device intended to be connected in an infusion line to an indwelling catheter and provide for the connection of a second infusion source. The second source usually serves to maintain a low keep vein open (KVO) flow in the catheter to prevent clotting. This device (the flush valve) may be equipped with a manually-operated mechanism to permit flushing of the line at a free-flow rate. This is a single-use device.falseActive40721Manual contrast medium injection systemAn assembly of devices designed for the manual-only injection of contrast media into the blood or lymphatic vessels of a patient for a diagnostic imaging procedure; it enables the operator to manually control the volume and rate of contrast media administered under pressure. The system typically consists of a graduated injection syringe, a manifold with multiple stopcocks, and a pressure transducer system used by the operator to monitor catheter-tip pressure.falseActive34926Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.falseActiveKNYAccessories, Catheter, G-UEZBStylet For Catheter, Gastro-UrologyODCEndoscope Channel AccessoryDXTInjector And Syringe, AngiographicEYBCatheter, Ureteral, Gastro-Urologytruefalse