{"publicDeviceRecordKey":"eb36d9d0-44df-4e7a-aa12-984cc8c5beba","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-03-01T00:00:00.000Z","devicePublishDate":"2019-03-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B504AC4330010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ArthroCare ","versionModelNumber":"AC4330-01","catalogNumber":null,"dunsNumber":"016889401","companyName":"Provision","deviceCount":1,"deviceDescription":null,"DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"541-422-8880","phoneExtension":null,"email":"mark@provisiondrs.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K173741","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61817","gmdnPTName":"Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed","gmdnPTDefinition":"A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NUJ","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation Accessories, Laparoscopic \u0026 Endoscopic, Reprocessed"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"32"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"7"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}