FDA.reportPublic FDA data

EVO sEEG Electrode

Primary DI
00856895008573
Brand
EVO sEEG Electrode
Company
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Model
NSEEG1605-RF
Device description
16mm x 5 Contact sEEG Electrode - RF Probe
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2
GZLElectrode, DepthNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856895008573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856895008573008568950085738568950085730856895008573

GMDN Terms#

Term, Definition table
TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105937669
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856895008153One RF Ablation SystemNRFPK0001-TNRF2025-09-01
00856895008139One RF Ablation System2708-TNRF2025-08-20
00856895008146One RF Ablation System1605-TNRF2025-08-20
00856895008634OneRF Ablation SystemNSEEG6216-RF2024-12-02
00856895008641OneRF Ablation SystemNSEEG6916-RF2024-12-02
00856895008658OneRF Ablation SystemNSEEG8016-RF2024-12-02
00856895008498OneRF Ablation SystemNRFGN00012024-03-15
00856895008504OneRF Ablation SystemNRFGS00012024-03-15
00856895008511OneRF Ablation SystemNRFBK00012024-03-15
00856895008528OneRF Ablation SystemNRFGC00012024-03-15
00856895008535OneRF Ablation SystemNRFFP00012024-03-15
00856895008559OneRF Ablation SystemNRFCH00012024-03-15
00856895008566OneRF Ablation SystemNRFPK00012024-03-15
00856895008580EVO sEEG ElectrodeNSEEG2708-RF2024-03-15
00856895008597EVO sEEG ElectrodeNSEEG3410-RF2024-03-15
00856895008603EVO sEEG ElectrodeNSEEG4112-RF2024-03-15
00856895008610EVO sEEG ElectrodeNSEEG4814-RF2024-03-15
00856895008627EVO sEEG ElectrodeNSEEG5516-RF2024-03-15
00856895008238EVO sEEG Electrode16mm x 5 Contact sEEG ElectrodeNSEEG16052021-09-27
00856895008252EVO sEEG Electrode33.5mm x 10 Contact sEEG ElectrodeNSEEG34102021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018179000Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179017Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179024Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179031Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179048Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179055Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179062Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179079Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179086Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179093Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
04048223070291RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070321RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070727RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070758RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070772RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223084939ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085257ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085264ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085387ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085394ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085424ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085431ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085448ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085455ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
00650551006749DEPTHALON®PMT CORPORATIONGZL2026-06-09
00841823111029Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-06-03
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18