{"publicDeviceRecordKey":"abcec2f5-c69a-4c08-8ff0-1054fcc4f30b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-03-11T00:00:00.000Z","devicePublishDate":"2020-03-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M7558720060","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"gSource ","versionModelNumber":"gS 87.2006","catalogNumber":"gS 87.2006","dunsNumber":"008162518","companyName":"GSOURCE LLC","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47874","gmdnPTName":"Orthopaedic ball spike","gmdnPTDefinition":"A hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HXX","productCodeName":"Screwdriver"}]},"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":[]}}