Global Reference Module 1 36-0301-0006

GUDID 00850011306734

The Global Reference Module 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 ID: 00850011306734
• NIH Device Record Key: e12e912f-80be-4353-930d-78fff47a9ed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Global Reference Module 1
• Version Model Number: Global Reference Module - 1
• Catalog Number: 36-0301-0006
• Company DUNS: 933200842
• Company Name: NEURALYNX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by NEURALYNX, INC.

• 00850011306338 - ATLAS Stim Headbox - Touchproof: 2025-06-19 ATLAS Stim Headbox with Touchproof side panel.
• 00850011306345 - ATLAS Stim Headbox - High Density: 2025-06-19 ATLAS Stim Headbox with High Density side panel.
• 00850011306703 - ATLAS Stim Headbox Software: 2025-06-19 Control software for the ATLAS Stim Headbox.
• 00850011306710 - Fiber Optic Connector 2m: 2025-06-19 Computer ethernet connection; 2m in length.
• 00850011306727 - Fiber Optic Connector 7m: 2025-06-19 Computer ethernet connection; 7m in length.
• 00850011306901 - ATLAS Headbox Interface Cable - Touchproof: 2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
• 00850011306918 - ATLAS Headbox Interface Cable - NK: 2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
• 00850011306925 - ATLAS Headbox Interface Cable - High Density: 2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.