{"publicDeviceRecordKey":"277651ff-3195-48c8-b283-e01c91200547","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-02-06T00:00:00.000Z","devicePublishDate":"2021-05-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10886982297822","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"04.043.255S","catalogNumber":"04043255S","dunsNumber":"486711679","companyName":"Synthes GmbH","deviceCount":1,"deviceDescription":"TIBIAL NAIL-ADVANCED / 10MM 405MM / STERILE","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":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)255-2500","phoneExtension":null,"email":"xx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K201336","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38152","gmdnPTName":"Tibia intramedullary nail","gmdnPTDefinition":"A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HWC","productCodeName":"Screw, fixation, bone"},{"productCode":"JDS","productCodeName":"NAIL, FIXATION, BONE"}]},"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}