{"publicDeviceRecordKey":"e8cc11eb-24fc-4a85-8d86-757e798415cf","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-30T00:00:00.000Z","devicePublishDate":"2022-09-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E235SSXTSAMPLE0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Super Snap X-Treme Sample Pack","versionModelNumber":"001","catalogNumber":"SSXT/SAMPLE","dunsNumber":"054618202","companyName":"SHOFU DENTAL CORPORATION","deviceCount":1,"deviceDescription":"Contains DIs: E235L5070; E235L5220; E235L5310; E235L5320; E23504390\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(760) 736-3277","phoneExtension":null,"email":"customer-service@shofu.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35807","gmdnPTName":"Dental abrasive disk, reusable","gmdnPTDefinition":"A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EHL","productCodeName":"Point, Abrasive"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"1"},"storageHandlingSpecialConditionText":null}]},"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":[]}}