{"publicDeviceRecordKey":"6b5c55c2-ca42-4316-911d-37cbc47757a0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-08-27T00:00:00.000Z","devicePublishDate":"2018-07-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"50749756955336","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00749756955331","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00749756955331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DeRoyal","versionModelNumber":"CA2-F","catalogNumber":null,"dunsNumber":"096372255","companyName":"DEROYAL INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"2800 Series AdapterLight Handle Cover With Flange","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)938-7828","phoneExtension":null,"email":"udisupport@deroyal.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45021","gmdnPTName":"Instrument/equipment drape, single-use, sterile","gmdnPTDefinition":"A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"FTA","productCodeName":"Light, surgical, accessories"}]},"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":[]}}