{"publicDeviceRecordKey":"9b9d8590-1020-43bc-b73a-6695d1f8c73f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-02-06T00:00:00.000Z","devicePublishDate":"2023-11-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08905892007293","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GPC","versionModelNumber":"ILBS59L-L","catalogNumber":null,"dunsNumber":"915882579","companyName":"GPC MEDICAL LIMITED","deviceCount":1,"deviceDescription":"intraHEAL Proximal Hip Stabilizing Nail, Long - S.S. - Left,Dia. 11 mm, 440 mm Length","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"9205302602","phoneExtension":null,"email":"info@gpcmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K143245","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44854","gmdnPTName":"Arthrodesis intramedullary nail, non-distracting","gmdnPTDefinition":"A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JDS","productCodeName":"Nail, Fixation, Bone"},{"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}