{"publicDeviceRecordKey":"7522363d-7c66-473d-a1b5-e3e9a45d41ce","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-14T00:00:00.000Z","devicePublishDate":"2022-09-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B8032905800","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORTHOMED","versionModelNumber":"OM 29-0580","catalogNumber":null,"dunsNumber":"086618626","companyName":"ORTHO-MED, INC.","deviceCount":1,"deviceDescription":"SCHAMBERG COMDNE EXTR 3 3/4\" STAND\n","DMExempt":false,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63105","gmdnPTName":"Orthopaedic instrument extractor","gmdnPTDefinition":"A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HWB","productCodeName":"Extractor"}]},"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":[]}}