{"publicDeviceRecordKey":"a8319050-9e93-4820-b02d-58170cd0ab98","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-09-15T00:00:00.000Z","devicePublishDate":"2023-09-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M397S2CDU72","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M397S2CDU70","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"M397S2CDU70","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M397S2CDU79","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M397S2CDU72","pkgQuantity":15,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"}]},"brandName":"PlasmaJet Neutral Plasma Surgery System","versionModelNumber":"S2-CDU-7","catalogNumber":"S2-CDU-7","dunsNumber":"360799048","companyName":"PLASMA SURGICAL, INC","deviceCount":1,"deviceDescription":"Single-Use Cut\\Coagulation Handpiece for Open Surgical for the PlasmaJet System","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"6785784390","phoneExtension":null,"email":"cs@plasmasurgical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K121977","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47275","gmdnPTName":"Plasma surgical system handpiece","gmdnPTDefinition":"A hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"7"},"sizeText":null,"sizeString":"Length: 7 Centimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}