{"publicDeviceRecordKey":"13177dab-5299-41b6-8bc6-fe8f272a532d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-04-19T00:00:00.000Z","devicePublishDate":"2022-04-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04946329068702","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Leg Traction Device","versionModelNumber":"08-115-12","catalogNumber":"08-115-12","dunsNumber":"690677802","companyName":"MIZUHO CORPORATION","deviceCount":1,"deviceDescription":"Lower Thigh Support for Traction in Lateral Posture","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"9999999999","phoneExtension":null,"email":"regulatory@mizuho.co.jp"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46511","gmdnPTName":"Surgical traction tensioner","gmdnPTDefinition":"A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GDC","productCodeName":"Table, Operating-Room, Electrical"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"240"},"sizeText":null,"sizeString":"Length: 240 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}