ATLAS-HS-36-CHET-A9 31-0601-0086

GUDID 10850011306212

The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-A9 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.

NEURALYNX, INC.

Electroencephalographic signal amplifier

• Primary Device ID: 10850011306212
• NIH Device Record Key: 295ec203-dba3-4bf9-914f-816442bc5a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS-HS-36-CHET-A9
• Version Model Number: ATLAS-HS-36-CHET-A9
• Catalog Number: 31-0601-0086
• 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: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850011306212 [Primary]

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2020-04-15
• Device Publish Date: 2020-04-07

On-Brand Devices [ATLAS-HS-36-CHET-A9]

• 10850011306212: The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode co
• 00850011306215: The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode co