{"publicDeviceRecordKey":"510648b1-fdc9-45eb-9fa5-049710a2c367","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-01-08T00:00:00.000Z","devicePublishDate":"2016-08-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033390063333","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Delta PF Cup","versionModelNumber":"Adapter","catalogNumber":"9055.51.310","dunsNumber":"432066322","companyName":"LIMACORPORATE SPA","deviceCount":1,"deviceDescription":"Adapter Small for Cups Wrench\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":"32871","gmdnPTName":"Surgical torque wrench, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MBL","productCodeName":"Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous"},{"productCode":"LPH","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"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,"premarketSubmissions":{"premarketSubmission":[]}}