{"publicDeviceRecordKey":"fbcca7ed-74a2-49f2-99ef-226efa4154c5","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-07T00:00:00.000Z","devicePublishDate":"2023-06-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"GYNX1410150","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"GYNX1410151","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Gynex","versionModelNumber":"14-1015","catalogNumber":null,"dunsNumber":"012997685","companyName":"GYNEX CORPORATION","deviceCount":5,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"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":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K982739","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45633","gmdnPTName":"Electrocautery system electrode","gmdnPTDefinition":"An active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to burn or sear body tissue. It is made of an appropriate metal and is typically used to stop bleeding (cauterization of blood vessels) and to treat superficial skin lesions (e.g., removal of warts). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HGI","productCodeName":"Electrocautery, Gynecologic (And Accessories)"}]},"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}