{"publicDeviceRecordKey":"d47ecac9-4cb3-49a7-81f4-8fefce20e55f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-09-01T00:00:00.000Z","devicePublishDate":"2022-12-31T00:00:00.000Z","deviceCommDistributionEndDate":"2024-12-31T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00645517319476","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Trulife","versionModelNumber":"RSC300-LV-1","catalogNumber":null,"dunsNumber":"289728891","companyName":"TRULIFE LIMITED","deviceCount":1,"deviceDescription":"CASH HING STRN/PUB LG VR BKPD 30","DMExempt":false,"premarketExempt":true,"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":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58757","gmdnPTName":"Spine thermoplastic splint system","gmdnPTDefinition":"An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IQF","productCodeName":"ORTHOSIS, CERVICAL-THORACIC, RIGID"}]},"deviceSizes":{"deviceSize":[]},"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":[]}}