Identity
- Trade Name
- Brain Gauge MD FDA UDI
- Generic Name
- Cognitive assessment software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000709408 FDA UDI
- FDA Product Code
- PTY FDA UDI
- GMDN Term
- Cognitive assessment software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 73 Millimeter FDA UDIWidth — 113 Millimeter FDA UDIHeight — 40 Millimeter FDA UDI
Category: Cognitive assessment software
Brain Gauge MD by Cortical Metrics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- T.O.V.A. — TOVA COMPANY, THE · U
- T.O.V.A. — TOVA COMPANY, THE · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cortical Metrics, Llc
Sources (1)
- FDA UDI 57e6cf00-1be5-407a-9d38-41299cd64a49 36 fields · synced Jun 6, 2026