{"publicDeviceRecordKey":"9fa59e8d-9057-41cc-994d-e85fa3fcdd08","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-07-23T00:00:00.000Z","devicePublishDate":"2018-06-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00650551136811","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PMT® Halo Systems","versionModelNumber":"1218-065","catalogNumber":"1218-065","dunsNumber":"039576871","companyName":"PMT CORPORATION","deviceCount":1,"deviceDescription":"HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ NO TRACTION BAIL","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-626-5463","phoneExtension":null,"email":"info@pmtcorp.com"},{"phone":"800-626-5463","phoneExtension":null,"email":"intl@pmtcorp.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K090733","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60367","gmdnPTName":"Cervical spine immobilization system, single-use","gmdnPTDefinition":"An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HAX","productCodeName":"Tong, Skull For Traction"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"78"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"58"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}