{"publicDeviceRecordKey":"50863732-ac1e-4f4d-8885-2dfac985114f","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-11-16T00:00:00.000Z","devicePublishDate":"2021-11-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033837933908","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Castellini","versionModelNumber":"PUMA ELI A R M CP","catalogNumber":"71LEXXXX","dunsNumber":"429341410","companyName":"CEFLA SOCIETA' COOPERATIVA","deviceCount":1,"deviceDescription":"The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental unit, dental handpieces, multifunction pedal and operating light.\nThis is a MODULAR version (\"M\"): the hydric unit is not present, the assistant's board is connected to the back of the chair, and the lamp (optional) is installed under the dental chair. The last four characters \"XXXX\" of the catalog number can be different alphanumeric characters.","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":"+1 (704)598-0020","phoneExtension":null,"email":"service@cefladental.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34991","gmdnPTName":"Dental delivery system","gmdnPTDefinition":"A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ELC","productCodeName":"Scaler, Ultrasonic"},{"productCode":"EIA","productCodeName":"Unit, Operative Dental"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"70"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"75"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null}]},"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":[]}}