{"publicDeviceRecordKey":"30557a30-395b-4040-817b-5d5c4728fcb0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-14T00:00:00.000Z","devicePublishDate":"2022-09-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G088DSESOLM0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Panacea","versionModelNumber":"DS-ESO-LM","catalogNumber":"DS-ESO-LM","dunsNumber":"103449711","companyName":"Blake Manufacturing, Inc.","deviceCount":1,"deviceDescription":"Panacea Static Elbow orthosis, size Large/Medium","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41053","gmdnPTName":"Elbow orthosis","gmdnPTDefinition":"A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IQI","productCodeName":"Orthosis, Limb Brace"}]},"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":[]}}