FDA.reportPublic FDA data

EVO Cable Assembly

Primary DI
00856895008375
Brand
EVO Cable Assembly
Company
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Model
EVO Cable Assembly
Catalog number
NEC1602
Device description
EVO Cable Assembly Only
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYCElectrode, Cortical
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2
GZLElectrode, DepthNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856895008375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856895008375008568950083758568950083750856895008375

GMDN Terms#

Term, Definition table
TermDefinition
Cortical electrodeA sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on 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 series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-426-1383CustomerService@N1MTC.com

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
00856895008573EVO sEEG ElectrodeNSEEG1605-RF2024-03-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006633CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006640CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006657CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006664CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006671CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006688CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006695CORTAC®PMT CORPORATIONGYC2026-06-04
00841823111029Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-06-03
10873263009625microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008796microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008802microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008819microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008826microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008833microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008840microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008857microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008871microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10873263008888microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008918microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12
03664539003900NADIXI MEDICALGZL2024-04-03
03664539003917NADIXI MEDICALGZL2024-04-03
27290114060879NeuroNav with MER HeadstageALPHA OMEGA ENGINEERING CO. LTD.GZL2024-01-08
10873263008680microTargeting™ ElectrodeFHC, INC.GZL2023-03-10
03664539003641NADIXI MEDICALGZL2022-10-10
03664539003658NADIXI MEDICALGZL2022-10-10