Device
The ATLAS Cart is a mobile accessory cart intended to support and position system components (including monitors) for use with a cleared neurophysiology system.
Manufacturer
NEURALYNX, INC.
NEURALYNX, INC.
Model: 31-0605-0169
Catalog: 31-0605-0169
DI: 00850011306314
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
The ATLAS Cart is a mobile accessory cart intended to support and position system components (including monitors) for use with a cleared neurophysiology system.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4bc9ad8e-7a34-4e7e-817e-1329406ff4ea
Distribution Status:
In Commercial Distribution
DUNS Number:
933200842
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:
00850011306314
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36740
Name: Electroencephalographic signal amplifier
Definition:
An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.
FDA Product Codes
OMC
Reduced- Montage Standard Electroencephalograph
Premarket Submissions
Submission Number:
K110967
Supplement Number:
000