{"publicDeviceRecordKey":"c94f427d-4fe7-420f-b9d3-d4695844182d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-12-23T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2018-10-28T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10607915111660","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00607915111663","pkgQuantity":1,"pkgDiscontinueDate":"2018-10-28","pkgStatus":"Not in Commercial Distribution","pkgType":null},{"deviceId":"00607915111663","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Acucise® Endopyelotomy System","versionModelNumber":"B1005","catalogNumber":null,"dunsNumber":"187129135","companyName":"APPLIED MEDICAL RESOURCES CORPORATION","deviceCount":1,"deviceDescription":"Kit Includes:\nB1201, URO TAMPONADE BALLOON CATH\nH-110, HANDLE 10CC LF\nSEAL-005, SURESEAL II, INT. BOX/10, CE\nUROWIRE","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1.949.713.8300","phoneExtension":null,"email":"contact@appliedmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46691","gmdnPTName":"Gastro-urological guidewire, single-use","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"35511","gmdnPTName":"Vascular catheter flush valve, continuous","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"40721","gmdnPTName":"Manual contrast medium injection system","gmdnPTDefinition":"An 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.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"34926","gmdnPTName":"Ureteral catheter","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KNY","productCodeName":"Accessories, Catheter, G-U"},{"productCode":"EZB","productCodeName":"Stylet For Catheter, Gastro-Urology"},{"productCode":"ODC","productCodeName":"Endoscope Channel Accessory"},{"productCode":"DXT","productCodeName":"Injector And Syringe, Angiographic"},{"productCode":"EYB","productCodeName":"Catheter, Ureteral, Gastro-Urology"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}