{"publicDeviceRecordKey":"fd46ee0a-be23-48d5-be21-92658ab8c30a","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-01-14T00:00:00.000Z","devicePublishDate":"2018-12-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07613353172015","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AIR-FLOW","versionModelNumber":"D","catalogNumber":"FT-221#HF/A/006","dunsNumber":"481233849","companyName":"E.M.S. Electro Medical Systems S.A.","deviceCount":1,"deviceDescription":"AIR-FLOW® handy 3.0 PERIO","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"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":"+41229944700","phoneExtension":null,"email":"udi@ems-ch.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K132480","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45406","gmdnPTName":"Dental abrasive air jet system handpiece","gmdnPTDefinition":"A hand-held, dental device that is a component of a dental abrasive air jet system and which is used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. This device is connected to the control unit that regulates the sources of pressurized air and temperate water. The abrasive, typically in the form of a powder that, depending upon the design of the delivery method, can be contained within a receptacle in this device or a receptacle within the control unit, is mixed with the air and water as this passes through. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EFB","productCodeName":"Handpiece, Air-Powered, Dental"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}