ATLAS HDSS 31-0602-0031

GUDID 10850011306328

The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiological System (K110967) by Neuralynx, Inc. but also the Quantum Amplifier by Natus Corporation. The ATLAS HDSS shares the buffered outputs from the electrode interface and routes them to both systems to be digitized.

NEURALYNX, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 10850011306328
• NIH Device Record Key: df849dd6-d48b-40fe-a20f-ed3c32f79ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS HDSS
• Version Model Number: ATLAS HDSS
• Catalog Number: 31-0602-0031
• Company DUNS: 933200842
• Company Name: NEURALYNX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	10850011306328 [Primary]

FDA Product Code

• IKD: Cable, Electrode

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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [ATLAS HDSS]

• 10850011306328: The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrod
• 00850011306321: The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrod