{"publicDeviceRecordKey":"2f38e140-024b-46be-8f0f-34080f6a4d1e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-08-20T00:00:00.000Z","devicePublishDate":"2016-09-15T00:00:00.000Z","deviceCommDistributionEndDate":"2019-08-19T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03700512985631","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"03700512975632","pkgQuantity":6,"pkgDiscontinueDate":"2019-08-19","pkgStatus":"Not in Commercial Distribution","pkgType":"Box 2"},{"deviceId":"03700512975632","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"03700512965633","pkgQuantity":10,"pkgDiscontinueDate":"2019-08-19","pkgStatus":"Not in Commercial Distribution","pkgType":"Box 1"},{"deviceId":"03700512965633","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Steel Guide Wire with PTFE, Straight, .035x150cm, Removable Stylet","versionModelNumber":"WG010135RS","catalogNumber":"WG010135RS","dunsNumber":"401020409","companyName":"Promepla","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+37797984232","phoneExtension":null,"email":"customer@rocamed.eu"}]},"gmdnTerms":{"gmdn":[{"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":"EYA","productCodeName":"Stylet, Ureteral"}]},"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":[]}}