{"publicDeviceRecordKey":"9dd28741-89ee-4666-ab8c-e8f3388a0582","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-04-30T00:00:00.000Z","devicePublishDate":"2024-04-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B8034700680","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORTHOMED","versionModelNumber":"OM 47-0068","catalogNumber":null,"dunsNumber":"086618626","companyName":"ORTHO-MED, INC.","deviceCount":1,"deviceDescription":"LANE BONE FCPS.   13\" W/O RATCHET\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":"46751","gmdnPTName":"Bone holding forceps","gmdnPTDefinition":"A manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HXD","productCodeName":"Clamp"}]},"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":[]}}