{"publicDeviceRecordKey":"24d3069e-23aa-46f8-8eb7-3fcd49775b7c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-02-07T00:00:00.000Z","devicePublishDate":"2022-03-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033390108065","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SMR STEMLESS","versionModelNumber":"9013.55.039","catalogNumber":"9013.55.039","dunsNumber":"432066322","companyName":"LIMACORPORATE SPA","deviceCount":1,"deviceDescription":"SMR STEMLESS - Reamer Shaft \n","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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47829","gmdnPTName":"Surgical instrument handle, non-torque-limiting","gmdnPTDefinition":"A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSD","productCodeName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented"},{"productCode":"KWT","productCodeName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented"},{"productCode":"PHX","productCodeName":"Shoulder Prosthesis, Reverse Configuration"},{"productCode":"KWS","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented"},{"productCode":"PAO","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}