{"publicDeviceRecordKey":"1bc17879-8c07-4797-9e64-f176c6b136f3","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2018-05-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04026575174751","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BiMobile","versionModelNumber":"184-260/09","catalogNumber":"184-260/09","dunsNumber":"315675488","companyName":"WALDEMAR LINK GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"BiMobile Liner - conventional UHMWPE ","DMExempt":true,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K171273","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44362","gmdnPTName":"Constrained polyethylene acetabular liner","gmdnPTDefinition":"A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MEH","productCodeName":"Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate"},{"productCode":"LZO","productCodeName":"Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented"}]},"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}