EVO Cortical Electrode

Basic Information

• Brand Name: EVO Cortical Electrode
• Primary DI: 00856895008405
• Version / Model: Cortical Electrode, 1x4
• Catalog Number: NECB1004
• Company Name: NEUROONE MEDICAL TECHNOLOGIES CORPORATION
• Labeler DUNS: 105937669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 1
• Public Version Date: 2022-02-08
• Public Version Status: New
• Public Device Record Key: b3938849-551e-4663-9ab6-fbbe6f11bb52

Device Description

EVO Cortical Electrode, 1x4 kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GYC	Electrode, Cortical	Neurology	882.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32545	Cortical electrode	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856895008405	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]