Identity
- Trade Name
- AMA Optics Brightness Acuity Meter FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare. FDA UDI
- Model / Reference
- GLARE-01-DEUCE FDA UDI
- Description
- A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare. FDA UDI
Identifiers
- Catalog Number
- BAM01 FDA UDI
- Primary DI / UDI-DI
- G506BAM010 FDA UDI
- FDA Product Code
- HOX FDA UDI
- GMDN Term
- Vision testing/training chart FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1150 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vision testing/training chart
AMA Optics Brightness Acuity Meter by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- AMA Optics, Inc.
Sources (1)
- FDA UDI dfe46e33-a265-4fc0-a970-514f69ffce13 34 fields · synced May 31, 2026