Model: 1
DI: 07290018971055
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c6df7a4a-3fb7-4b36-9ffa-66aa78d58a9a
Distribution Status:
In Commercial Distribution
DUNS Number:
600237370
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290018971055
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63131
Name: Electroencephalographic electrode cap, reusable
Definition:
An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a reusable device.
FDA Product Codes
GXY
Electrode, Cutaneous
Premarket Submissions
Submission Number:
K243243
Supplement Number:
000