Identity
- Trade Name
- Optego FDA UDI
- Generic Name
- Vision testing/training flipper FDA UDI
- Device Name
- Optego Spherical Flipper, +1.00/-3.00 FDA UDI
- Model / Reference
- 94254 FDA UDI
- Description
- Optego Spherical Flipper, +1.00/-3.00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00360843007650 FDA UDI
- FDA Product Code
- HPC FDA UDI
- GMDN Term
- Vision testing/training flipper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1405 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 flipper
Optego by Optego Vision USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vision testing/training flipper.
- Alcon — Alcon Laboratories, Inc. · Class I
- Alcon — Alcon Laboratories, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, 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
- Optego Vision USA, Inc.
Sources (1)
- FDA UDI 23002b37-f450-4d2f-bba6-c0fa7f501a33 33 fields · synced Jun 6, 2026