{"publicDeviceRecordKey":"bdf68372-80af-4db9-98d4-edaa1c57b129","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-10-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"GYNX35360","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Teale Tenaculum, Slight Curve","versionModelNumber":"3536","catalogNumber":null,"dunsNumber":"012997685","companyName":"GYNEX CORPORATION","deviceCount":1,"deviceDescription":null,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K980247","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32598","gmdnPTName":"Uterine fibroid hook","gmdnPTDefinition":"A shaft-like surgical instrument whose distal end tapers to form a hook or multiple hooks used to fix or apply traction to uterine fibroids during a gynaecological procedure. It is typically a one-piece instrument made of high-grade stainless steel with a handle at the proximal end that is available in various shapes. In multiple hook designs, the hooks are in parallel. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"HDC","productCodeName":"Tenaculum, Uterine"}]},"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}