{"publicDeviceRecordKey":"0ea5ec75-5f3d-4340-ae34-65a0828b7197","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-04-17T00:00:00.000Z","devicePublishDate":"2022-11-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B382SD8043010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Surgical Direct","versionModelNumber":"SD804-301","catalogNumber":"SD804-301","dunsNumber":"124367223","companyName":"Surgical Direct, Inc.","deviceCount":1,"deviceDescription":"4mm 30 Degree Cystoscope, Autoclave, High Performance German Optics, Storz Fit","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (800) 519-3293","phoneExtension":null,"email":"info@surgicaldirect.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K031972","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17145","gmdnPTName":"Rigid optical cystoscope","gmdnPTDefinition":"An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HRX","productCodeName":"Arthroscope"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}