ATLAS HD HEADBOX 31-0601-0131

GUDID 10850011306359

The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68 connector to interface with the ATLAS Neurophysiology System. The ATLAS HD Headbox allows two MDR-68 connectors to be tied in parallel and a switch to disable active driven ground supplied by the ATLAS Neurophysiology system.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 10850011306359
• NIH Device Record Key: 05104d3b-9060-4b64-beec-2ec5baf0e581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS HD HEADBOX
• Version Model Number: ATLAS HD HEADBOX
• Catalog Number: 31-0601-0131
• 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: 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	10850011306359 [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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [ATLAS HD HEADBOX]

• 10850011306359: The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68
• 00850011306352: The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68