{"publicDeviceRecordKey":"1c11c798-684d-4e3d-ba83-d96c39037f6b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":9,"publicVersionDate":"2024-08-26T00:00:00.000Z","devicePublishDate":"2018-09-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00888118063243","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"REDUCTION INSTRUMENT","versionModelNumber":"38-708-00-07","catalogNumber":null,"dunsNumber":"826499238","companyName":"KLS-Martin L.P.","deviceCount":1,"deviceDescription":"CARROL GIRARD, SINGLE USE, 3.5 MM DIAMETER TIP","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":[{"phone":"+1(904)641-7746","phoneExtension":null,"email":"KLS-UDI-Info@klsmartin.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48024","gmdnPTName":"Orthopaedic bone-fragment manipulator, single-use","gmdnPTDefinition":"A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. 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":"10 CM"}]},"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":[]}}