{"publicDeviceRecordKey":"826fa805-9bf0-4a5b-a87a-2d9724ad0566","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-08-11T00:00:00.000Z","devicePublishDate":"2021-08-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00749756157469","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DeRoyal","versionModelNumber":"AD3005-00","catalogNumber":"AD3005-00","dunsNumber":"096372255","companyName":"DEROYAL INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"Leg Lifter","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"+1(888)938-7828","phoneExtension":null,"email":"udisupport@deroyal.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31052","gmdnPTName":"Assistive dressing/undressing hook/stick","gmdnPTDefinition":"A device typically in the form of a hook with a handle, or a long stick with a handle and a hook at the distal end, designed to be used by a person with a disability to hook, fix, or grasp a garment to manoeuvre and adjust it while dressing or undressing.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ILW","productCodeName":"ADAPTOR, GROOMING"}]},"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":[]}}