<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>e0f7f3e9-b7fa-4309-a4bc-a415831186f7</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-03-25</publicVersionDate><devicePublishDate>2024-03-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00856895008597</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>EVO sEEG Electrode</brandName><versionModelNumber>NSEEG3410-RF</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>105937669</dunsNumber><companyName>NEUROONE MEDICAL TECHNOLOGIES CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>33.5mm x 10 Contact sEEG - RF Probe</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>32556</gmdnCode><gmdnPTName>Depth electrode</gmdnPTName><gmdnPTDefinition>An electrical conductor intended to be temporarily placed (&lt; 30 days) beneath the surface of the brain to stimulate the brain or to record the brain&apos;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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>62055</gmdnCode><gmdnPTName>Percutaneous radio-frequency ablation probe, brain-ablation</gmdnPTName><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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GXI</productCode><productCodeName>Probe, Radiofrequency Lesion</productCodeName></fdaProductCode><fdaProductCode><productCode>GZL</productCode><productCodeName>Electrode, Depth</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>