{"publicDeviceRecordKey":"aa1498c8-8de6-44c8-97e7-cddcaa883b43","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-11-14T00:00:00.000Z","devicePublishDate":"2019-11-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00819251023917","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Hooded Acetabular Insert Trial ","versionModelNumber":"1223.52.036","catalogNumber":null,"dunsNumber":"078416717","companyName":"TOTAL JOINT ORTHOPEDICS, INC.","deviceCount":1,"deviceDescription":"Hooded Acetabular Insert Trial, 36mm ID, 52mm ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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":[{"phone":"+1(801)486-6070","phoneExtension":null,"email":"udi@tjoinc.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62303","gmdnPTName":"Acetabulum prosthesis trial, prefabricated, single-use","gmdnPTDefinition":"A copy of a final acetabular cup prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer materials and may be designed in the form of cages, shells or inserts. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"ORTHOPEDIC MANUAL SURGICAL INSTRUMENT"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"36mm ID, 52mm"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"The Klassic HD Hip System should be stored in a clean, dry location at room \ntemperature "}]},"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":[]}}