{"publicDeviceRecordKey":"30bd7ba7-f3e9-443a-b12a-60449d3d655c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-07-29T00:00:00.000Z","devicePublishDate":"2021-07-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00749756552004","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DeRoyal","versionModelNumber":"2039-01","catalogNumber":"2039-01","dunsNumber":"096372255","companyName":"DEROYAL INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"DARCO® SLIMLINE CAST BOOT","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)938-7828","phoneExtension":null,"email":"udisupport@deroyal.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32462","gmdnPTName":"Cast shoe, single-use","gmdnPTDefinition":"A footwear designed to be worn over a foot that is encased in a cast in order to protect the cast material and add stability for the patient while ambulating. Its foot bed provides comfort when ambulating and it may or may not protect the toes. It is available in a variety of designs and sizes and can be typically used both indoors and outdoors; some types may be used without a cast, e.g., in the case of a toe fracture. This is a disposable device that is intended for a single-patient use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IPG","productCodeName":"SHOE, CAST"}]},"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":[]}}