{"publicDeviceRecordKey":"e6833fa3-56db-4736-8cb6-bf027789a4c2","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-02-16T00:00:00.000Z","devicePublishDate":"2023-02-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10609271069012","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00609271069015","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00609271069015","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"20609271069019","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00609271069015","pkgQuantity":36,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"}]},"brandName":"Cast boot, canvas","versionModelNumber":"CBO0","catalogNumber":"CBO0","dunsNumber":"184231298","companyName":"DARCO INTERNATIONAL, INC.","deviceCount":1,"deviceDescription":"Extra-small  Navy Open-toe","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"10667","gmdnPTName":"Cast boot","gmdnPTDefinition":"A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.","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":[]}}