{"publicDeviceRecordKey":"02723c34-3a84-4d5d-877d-137ea3ca5423","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-11-14T00:00:00.000Z","devicePublishDate":"2015-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2025-01-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963937652","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AS ENDURO","versionModelNumber":"NR873Z","catalogNumber":"NR873Z","dunsNumber":"315018218","companyName":"Aesculap AG","deviceCount":1,"deviceDescription":"AS ENDURO MENISCAL COMPONENT F1 16MM","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":"33692","gmdnPTName":"Rotating hinged total knee prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KRO","productCodeName":"PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Height : 16.000 MM"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Figure/Size : F1"}]},"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":[]}}