{"publicDeviceRecordKey":"0cb82cef-09f6-49f4-ade1-4dbba0aa7079","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-12-16T00:00:00.000Z","devicePublishDate":"2016-08-24T00:00:00.000Z","deviceCommDistributionEndDate":"2023-05-06T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04546540246776","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"60-15120","catalogNumber":"60-15120","dunsNumber":"316153956","companyName":"Stryker Leibinger GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"DRILL, WL 20MM, STRYKER-SHAFT","DMExempt":true,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K070876","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":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter: 1.5 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"20.0"},"sizeText":null,"sizeString":"Length: 20.0 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"135.0"},"sizeText":null,"sizeString":"Length: 135.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}