{"publicDeviceRecordKey":"ea08a120-fd1b-4a68-b47b-2094e1dec0b0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-05-30T00:00:00.000Z","devicePublishDate":"2022-04-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887868504136","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Comprehensive® SRS Instrument","versionModelNumber":"405208","catalogNumber":"405208","dunsNumber":"129278169","companyName":"Biomet Orthopedics, LLC","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)348-9500","phoneExtension":null,"email":"customerservice@zimmerbiomet.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K111746","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60936","gmdnPTName":"Humeral stem prosthesis trial, reusable","gmdnPTDefinition":"A copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWS","productCodeName":"PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED"},{"productCode":"JDC","productCodeName":"PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED"},{"productCode":"KWT","productCodeName":"PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED"},{"productCode":"MBF","productCodeName":"PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"18 mm X 100 mm"}]},"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}