{"publicDeviceRecordKey":"fc205499-0624-412d-9435-b08e74db1e9c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-12-07T00:00:00.000Z","devicePublishDate":"2018-11-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ESRL58902801","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GIALLOY CB/N","versionModelNumber":"5890280 Neutral 10 x 1 kg Dose","catalogNumber":null,"dunsNumber":"313446764","companyName":"SRL Dental GmbH","deviceCount":1,"deviceDescription":"Aufbrennfähige Nichtedelmetall-Dental-Gusslegierung auf Nickel-Basis, Typ 3 / \nNPM - Nickel-based dental alloy for casting, type 3 / \nNeutral 10 x 1 kg Dose ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35857","gmdnPTName":"Dental casting non-noble alloy","gmdnPTDefinition":"A material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EJH","productCodeName":"Alloy, Metal, Base"}]},"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":[]}}