{"publicDeviceRecordKey":"7d040277-1f7b-4178-9cf3-b5bfcfe18a2d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2023-09-07T00:00:00.000Z","devicePublishDate":"2015-08-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03596010456830","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"71362745","catalogNumber":"71362745","dunsNumber":"045483575","companyName":"Smith \u0026 Nephew, Inc.","deviceCount":1,"deviceDescription":"REFLECTION REAMER DOME 45MM","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)821-5700","phoneExtension":null,"email":"gudid@smith-nephew.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K123598","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32848","gmdnPTName":"Acetabular orthopaedic reamer","gmdnPTDefinition":"An orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JDG","productCodeName":"Prosthesis, hip, femoral component, cemented, metal"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}