Brain Gauge MD

GUDID 00860000709408

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.

CORTICAL METRICS, LLC

Cognitive assessment software

• Primary Device ID: 00860000709408
• NIH Device Record Key: 57e6cf00-1be5-407a-9d38-41299cd64a49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brain Gauge MD
• Version Model Number: 1.0
• Company DUNS: 809217487
• Company Name: CORTICAL METRICS, LLC
• 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: true
• 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: 919-903-9943
• Email: support@corticalmetrics.com

Device Dimensions

• Height: 40 Millimeter
• Height: 40 Millimeter
• Height: 40 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000709408 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-11-27