{"publicDeviceRecordKey":"86a5e697-d59a-484b-9adb-74c0c9a0828b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2020-09-09T00:00:00.000Z","devicePublishDate":"2015-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04712771494792","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"United Hip System, U2 Bipolar Implant\t\t","versionModelNumber":"1503-3669","catalogNumber":"1503-3669","dunsNumber":"656700556","companyName":"UNITED ORTHOPEDIC CORP.","deviceCount":1,"deviceDescription":"U2 Bipolar Implant, 36mm I.D., 69mm O.D \n","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":"+886229294567","phoneExtension":null,"email":"service@uoc.com.tw"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K101670","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33695","gmdnPTName":"Bipolar femoral head outer component, hemiarthroplasty","gmdnPTDefinition":"An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWY","productCodeName":"Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"69"},"sizeText":null,"sizeString":"Outer Diameter: 69 Millimeter"},{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"36"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 36 Millimeter"}]},"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}