ATLAS TTL Isolator 31-0604-0060

GUDID 00850011306178

The ATLAS TTL Isolator is an optional configuration of the ATLAS Neurophysiology System that isolates two of the four 8 bit TTL Ports on the front of the system.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 00850011306178
• NIH Device Record Key: 7567ed8a-c015-48c6-bd0e-fad09b8fc9c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS TTL Isolator
• Version Model Number: ATLAS TTL Isolator
• Catalog Number: 31-0604-0060
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306178 [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: 2022-09-27
• Device Publish Date: 2022-09-19

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.