{"publicDeviceRecordKey":"8e49e322-79c2-4e56-bffa-cba9acdffd25","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-07-23T00:00:00.000Z","devicePublishDate":"2018-06-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B267C220","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Flow-Nail™        ","versionModelNumber":"C22","catalogNumber":"C22","dunsNumber":"079293587","companyName":"Flow-FX","deviceCount":1,"deviceDescription":"FN 22mm CORT Screw\n","DMExempt":false,"premarketExempt":false,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K140601","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"56643","gmdnPTName":"Femur nail, non-sterile","gmdnPTDefinition":"A non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSB","productCodeName":"Rod, Fixation, Intramedullary And Accessories"}]},"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}