Modular Headstage-36 31-0601-0091

GUDID 10850011306137

The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 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: 10850011306137
• NIH Device Record Key: 25d14403-9ea5-48cd-b922-f721e8c6ba8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Headstage-36
• Version Model Number: Modular Headstage-36
• Catalog Number: 31-0601-0091
• 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
• 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	10850011306137 [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 [Modular Headstage-36]

• 10850011306137: The Modular Headstage-36 is a clinical headstage that connects to one of several modular electro
• 00850011306130: The Modular Headstage-36 is a clinical headstage that connects to one of several modular electro