{"publicDeviceRecordKey":"0cf667d4-fbf2-4786-b35d-0b6baf34aaa7","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-04-13T00:00:00.000Z","devicePublishDate":"2022-04-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850608002575","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"POWERX","versionModelNumber":"115-0018","catalogNumber":"115-0018","dunsNumber":"079999584","companyName":"SOLTA MEDICAL","deviceCount":1,"deviceDescription":"ACCESSORY KIT, POWERX SYSTEM\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36273","gmdnPTName":"Ultrasonic surgical system generator","gmdnPTDefinition":"An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"QPB","productCodeName":"System, Suction, Lipoplasty For Removal"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}