{"publicDeviceRecordKey":"4e3613a7-1e02-42ef-979a-d326ffb2f1f3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-09-02T00:00:00.000Z","devicePublishDate":"2018-09-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00821925035522","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00821925041295","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"00821925041295","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DIEGO ELITE","versionModelNumber":"SB4015SC","catalogNumber":null,"dunsNumber":"007198742","companyName":"Gyrus ACMI, LLC","deviceCount":1,"deviceDescription":"SHAVER BLADE, 4 MM, 15 DEGREES, STANDARD, SERRATED, CLOSED, DIEGO ELITE","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34848","gmdnPTName":"Metal/carbide ENT bur, single-use","gmdnPTDefinition":"A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EQJ","productCodeName":"BUR, EAR, NOSE AND THROAT"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}