Identity
- Trade Name
- Artificial Eye, Plastic, Custom FDA UDI
- Generic Name
- Eyeball prosthesis, custom-made FDA UDI
- Model / Reference
- V2623 FDA UDI
Identifiers
- Catalog Number
- E661087 FDA UDI
- Primary DI / UDI-DI
- B863E661087V2623 FDA UDI
- FDA Product Code
- HQH FDA UDI
- GMDN Term
- Eyeball prosthesis, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.3200 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eyeball prosthesis, custom-made
Artificial Eye, Plastic, Custom by Texas Eye Prosthetics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyeball prosthesis, custom-made.
- Eye, Artificial, Non-Custom — MIDWEST EYE LABORATORIES, INC. · Class I
- Eye, Artificial, Non-Custom — MIDWEST EYE LABORATORIES SIOUX FALLS LLC · Class I
- Artificial Eye, Plastic, Custom — Legrand Associates · Class I
- Artificial Eye — THE EYE CONCERN, INC. · Class I
- Eye, Artificial, Non-Custom — MIDWEST EYE LABORATORIES WOODBURY LLC · Class I
- Artificial Eye, Plastic, Custom — THOMPSON OCULAR PROSTHETICS, INC. · Class I
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
- Texas Eye Prosthetics Llc
Sources (1)
- FDA UDI e5155c1d-e553-4a99-8d97-a214bc362855 34 fields · synced May 31, 2026