{"publicDeviceRecordKey":"c3f67a19-69e6-4475-bc29-f4aadcb46e40","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-08T00:00:00.000Z","devicePublishDate":"2022-11-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H66816622150","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"H66816622151","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bosworth Flexo","versionModelNumber":"1662215","catalogNumber":"1662215","dunsNumber":"073503117","companyName":"Keystone Industries","deviceCount":100,"deviceDescription":"DISPOSABLE SALIVA EJECTORS WHITE","DMExempt":false,"premarketExempt":true,"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)333-3131","phoneExtension":"8455","email":"tschwear@keystoneind.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37434","gmdnPTName":"Dental suction system cannula, single-use","gmdnPTDefinition":"A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYN","productCodeName":"Mouthpiece, saliva ejector"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}