Global Reference Module 13 31-0604-0055

GUDID 00850011306635

The Global Reference Module 13 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.

NEURALYNX, INC.

Electroencephalographic signal amplifier
Primary Device ID00850011306635
NIH Device Record Key6b5d587b-8597-42e0-b6b0-9deb5c012edb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlobal Reference Module 13
Version Model NumberGlobal Reference Module - 13
Catalog Number31-0604-0055
Company DUNS933200842
Company NameNEURALYNX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306635 [Primary]

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-18
Device Publish Date2022-11-10

Devices Manufactured by NEURALYNX, INC.

00850011306338 - ATLAS Stim Headbox - Touchproof2025-06-19 ATLAS Stim Headbox with Touchproof side panel.
00850011306345 - ATLAS Stim Headbox - High Density2025-06-19 ATLAS Stim Headbox with High Density side panel.
00850011306703 - ATLAS Stim Headbox Software2025-06-19 Control software for the ATLAS Stim Headbox.
00850011306710 - Fiber Optic Connector 2m2025-06-19 Computer ethernet connection; 2m in length.
00850011306727 - Fiber Optic Connector 7m2025-06-19 Computer ethernet connection; 7m in length.
00850011306901 - ATLAS Headbox Interface Cable - Touchproof2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
00850011306918 - ATLAS Headbox Interface Cable - NK2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
00850011306925 - ATLAS Headbox Interface Cable - High Density2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.