{"publicDeviceRecordKey":"947351a2-9805-455c-9e8f-4ae19e49fcef","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-09-07T00:00:00.000Z","devicePublishDate":"2015-08-29T00:00:00.000Z","deviceCommDistributionEndDate":"2018-03-25T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03596010562425","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"EMPERION","versionModelNumber":"71291827","catalogNumber":"71291827","dunsNumber":"045483575","companyName":"Smith \u0026 Nephew, Inc.","deviceCount":1,"deviceDescription":"EMPERION SLEEVE 21 LG CONE3 SPOUT SLOTTED","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)238-7538","phoneExtension":null,"email":"GUDID@SMITH-NEPHEW.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K052426","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33581","gmdnPTName":"Coated hip femur prosthesis, modular","gmdnPTDefinition":"A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MEH","productCodeName":"Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate"}]},"deviceSizes":{"deviceSize":[]},"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}