{"publicDeviceRecordKey":"af1303ac-cd00-42c2-9630-39cdd1873a16","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-08-23T00:00:00.000Z","devicePublishDate":"2022-08-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G088HSFPL0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BMI","versionModelNumber":"HSF-PL","catalogNumber":"HSF-PL","dunsNumber":"103449711","companyName":"Blake Manufacturing, Inc.","deviceCount":1,"deviceDescription":"FlexEze Slim Grip Hand orthosis, size: Petite, side: Left","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":"41459","gmdnPTName":"Wrist/hand orthosis","gmdnPTDefinition":"An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ILH","productCodeName":"Splint, Hand, And Components"}]},"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":[]}}