{"publicDeviceRecordKey":"ec722b25-9d5e-4f10-8520-d7b02f1f3045","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-03-27T00:00:00.000Z","devicePublishDate":"2020-03-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07613353196318","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PIEZON","versionModelNumber":"FS-307","catalogNumber":null,"dunsNumber":"481233849","companyName":"E.M.S. Electro Medical Systems S.A.","deviceCount":1,"deviceDescription":"SURGERY MASTER SYSTEM","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":"+41229944700","phoneExtension":null,"email":"udi@ems-ch.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K072146","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47014","gmdnPTName":"Dental ultrasonic surgical system handpiece","gmdnPTDefinition":"A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZI","productCodeName":"Drill, Bone, Powered"}]},"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}