{"publicDeviceRecordKey":"9e36f848-9387-4245-9e2b-187c4b3736ac","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-11-13T00:00:00.000Z","devicePublishDate":"2015-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2025-01-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963741174","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Isodur®","versionModelNumber":"NJ136K","catalogNumber":"NJ136K","dunsNumber":"315018218","companyName":"Aesculap AG","deviceCount":1,"deviceDescription":"ISODUR PROSTHESIS HEAD 8/10 36MM S","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":"+1(800)282-9000","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33175","gmdnPTName":"Metallic femoral head prosthesis","gmdnPTDefinition":"An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LZO","productCodeName":"Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Neck length : - 3.5"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Taper Size : 8/10"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Outer diameter (mm) : 36.000 MM"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Figure/Size : Size S"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}