{"publicDeviceRecordKey":"de6d6472-a6b0-49a9-bba4-0b20acc4ca79","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-10-03T00:00:00.000Z","devicePublishDate":"2022-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08031497002248","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CEMENT PRESSURIZER","versionModelNumber":"PRZ-01","catalogNumber":null,"dunsNumber":"435428396","companyName":"TECRES SPA","deviceCount":1,"deviceDescription":"Cement Pressurizer is intended to be used in cemented arthroplasty for the pressurization of the cement inside the femoral canal during retrograde filling. ","DMExempt":false,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46031","gmdnPTName":"Orthopaedic cement compressor","gmdnPTDefinition":"A device used to apply pressure to orthopaedic bone cement during a total hip arthroplasty (THA) procedure (within the acetabulum and/or femur) in order to optimise inner bone (cancellous) cement interdigitation to improve fixation of the implant. The device is typically made of a compressible silicone rubber which conforms to the shape of the cut bone to enable formation of a good seal. Cement may be injected through the device into the bone cavity using an appropriate syringe; pressure may be applied to the device with a firm handle (e.g., stainless steel), or a backplate. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"Orthopedic Manual Surgical Instrument"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}