{"publicDeviceRecordKey":"84e82207-0451-4dcf-8dd6-a6dcc98f34ba","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2020-07-23T00:00:00.000Z","devicePublishDate":"2016-12-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00613994952011","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"POWEREASE™ Instruments","versionModelNumber":"G2345042S","catalogNumber":null,"dunsNumber":"830350380","companyName":"MEDTRONIC SOFAMOR DANEK, INC.","deviceCount":1,"deviceDescription":"DRILL BIT G2345042S 4.2MM DRILL BIT","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K111520","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"43390","gmdnPTName":"Fluted surgical drill bit, single-use","gmdnPTDefinition":"A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a \"twist drill\", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HBE","productCodeName":"DRILLS, BURRS, TREPHINES \u0026 ACCESSORIES (SIMPLE, POWERED)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"4.2"},"sizeText":null,"sizeString":"Outer Diameter: 4.2 Millimeter"}]},"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}