{"publicDeviceRecordKey":"5140104d-ae67-43d8-bbfb-b0e5555f802e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-07-14T00:00:00.000Z","devicePublishDate":"2016-03-09T00:00:00.000Z","deviceCommDistributionEndDate":"2021-07-14T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09340499005447","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GRU Femur","versionModelNumber":"GRU-RL/LM-1F-C","catalogNumber":"GRU-RL/LM-1F-C","dunsNumber":"752039982","companyName":"GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED","deviceCount":1,"deviceDescription":"GRU Femur RLLM Size 1","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+6128870100","phoneExtension":null,"email":"info@globalortho.com.au"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K051721","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33369","gmdnPTName":"Uncoated unicondylar knee femur prosthesis","gmdnPTDefinition":"A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HRY","productCodeName":"Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size 0"}]},"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}