{"publicDeviceRecordKey":"120abbe1-df69-4832-a802-c029bcb73d45","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-03-25T00:00:00.000Z","devicePublishDate":"2024-03-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00856895008610","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"EVO sEEG Electrode","versionModelNumber":"NSEEG4814-RF","catalogNumber":null,"dunsNumber":"105937669","companyName":"NEUROONE MEDICAL TECHNOLOGIES CORPORATION","deviceCount":1,"deviceDescription":"47.5mm x 14 Contact sEEG - RF Probe","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":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32556","gmdnPTName":"Depth electrode","gmdnPTDefinition":"An electrical conductor intended to be temporarily placed (\u003c 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"62055","gmdnPTName":"Percutaneous radio-frequency ablation probe, brain-ablation","gmdnPTDefinition":"A semi-flexible, hand-held instrument intended to be percutaneously introduced via a dedicated cannula under stereotactic guidance [e.g., using pre-acquired magnetic resonance imaging (MRI) images and fluoroscopy] to deliver radio-frequency current in a monopolar configuration from a system generator for the surgical ablation of brain tissues (e.g., during amygdalohippocampectomy). It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GXI","productCodeName":"Probe, Radiofrequency Lesion"},{"productCode":"GZL","productCodeName":"Electrode, Depth"}]},"deviceSizes":{"deviceSize":[]},"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,"premarketSubmissions":{"premarketSubmission":[]}}