{"publicDeviceRecordKey":"b73d76ed-17e7-4e59-8101-477d686f6865","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-08-09T00:00:00.000Z","devicePublishDate":"2023-08-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"05055348201058","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Elbow","versionModelNumber":"Adolescent Forearm, 64mm, 50mm Wrist, Flesh Pink","catalogNumber":"C10552PK","dunsNumber":"210280350","companyName":"HUGH STEEPER LIMITED","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41097","gmdnPTName":"Body-powered elbow prosthesis, locking","gmdnPTDefinition":"An artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of connecting straps/cables or other mechanism powered by the movement of body segments, or it moves as the result of a connection with another functional limb component. The position of the device can be maintained by a locking mechanism that is body- or externally-powered.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IRD","productCodeName":"Joint, Elbow, External Limb Component, Mechanical"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}