{"publicDeviceRecordKey":"d7543c56-47d8-4347-a5f4-ed03c5a85bdb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2018-01-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033390133746","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Patellar Resection Guide","versionModelNumber":"Patellar Resection Guide","catalogNumber":"9065.95.2A5","dunsNumber":"432066322","companyName":"LIMACORPORATE SPA","deviceCount":1,"deviceDescription":"Patellar Resection Guide – Right Small\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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K151266","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45109","gmdnPTName":"Orthopaedic reamer guide","gmdnPTDefinition":"An orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JWH","productCodeName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Right Small"}]},"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}