{"publicDeviceRecordKey":"0166f11a-0858-48d8-9de4-b4b3dbd9fb6a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-01-20T00:00:00.000Z","devicePublishDate":"2018-05-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M68955110010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PRO PELVIC SPLINT","versionModelNumber":"01","catalogNumber":"55-110","dunsNumber":"118492643","companyName":"Safeguard US Operating, LLC","deviceCount":1,"deviceDescription":"PRO PELVIC SPLINT\n1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle\nIntended for the emergency management of suspected pelvic fracture(s).","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":true,"contacts":{"customerContact":[{"phone":"855-428-6074","phoneExtension":null,"email":"fulfillment@combatmedicalsystems.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63255","gmdnPTName":"Pelvic fracture binder, reusable","gmdnPTDefinition":"A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSQ","productCodeName":"Belt, Pelvic, Traction"}]},"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":[]}}