Device
PLATINUM, 2MM, 4 CONTACT, 4MM CTC, 1X4 GRID, #1 RADIOPAQUE, SMOOTH, 1 EXIT, 1 TAIL, IOM, ALL CONTACT NUMBERED, 7FT LEAD, EEG PLUG
Manufacturer
PMT CORPORATION
PMT CORPORATION
Model: 2110-04-090
DI: 00650551005858
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
PLATINUM, 2MM, 4 CONTACT, 4MM CTC, 1X4 GRID, #1 RADIOPAQUE, SMOOTH, 1 EXIT, 1 TAIL, IOM, ALL CONTACT NUMBERED, 7FT LEAD, EEG PLUG
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1177c9aa-b6d8-4b76-84b0-05a646318442
Distribution Status:
In Commercial Distribution
DUNS Number:
039576871
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00650551005858
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32545
Name: Cortical electrode
Definition:
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.
FDA Product Codes
GYC
Electrode, Cortical
Premarket Submissions
Submission Number:
K082474
Supplement Number:
000