{"publicDeviceRecordKey":"2d59f043-f4a9-47d4-96ae-b8a3a1288e58","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2018-11-22T00:00:00.000Z","devicePublishDate":"2017-04-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ENOU1960NOU0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Surgical handpiece 1:1","versionModelNumber":"1960nou","catalogNumber":null,"dunsNumber":"480610476","companyName":"Nouvag AG","deviceCount":1,"deviceDescription":"Surgical handpiece angled 70mm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+41718466600","phoneExtension":null,"email":"info@nouvag.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K042434","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37867","gmdnPTName":"Surgical power tool system handpiece, rotary, rechargeable battery-powered","gmdnPTDefinition":"A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by an attached rechargeable battery pack to directly provide low-voltage electricity to the motor of the handpiece. The device may be cannulated to allow the use of a guidewire. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"ERL","productCodeName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece"}]},"deviceSizes":{"deviceSize":[]},"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}