Device
PLATINUM, 2MM CONTACT, 64 CONTACTS, 5MM SPACING (CTC), 8X8 GRID, #1 RADIOOPAQUE, SMOOTH, INLINE, 4 EXIT, 4 LEADS, 4 TAILS, REVERSE ALL CONTACT NUMBERS, 0.76MM THICK
Manufacturer
PMT CORPORATION
PMT CORPORATION
Model: 2110-64-013
DI: 00650551005902
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 CONTACT, 64 CONTACTS, 5MM SPACING (CTC), 8X8 GRID, #1 RADIOOPAQUE, SMOOTH, INLINE, 4 EXIT, 4 LEADS, 4 TAILS, REVERSE ALL CONTACT NUMBERS, 0.76MM THICK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2a4fc6f4-7996-4b4c-9f4f-2597f5344050
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:
00650551005902
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