Identity
- Trade Name
- Optego FDA UDI
- Generic Name
- Tinted non-prescription spectacle lens FDA UDI
- Device Name
- Roller-Shadz®, Charcoal, 100/bag FDA UDI
- Model / Reference
- 98343 FDA UDI
- Description
- Roller-Shadz®, Charcoal, 100/bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00360843009142 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacle lens FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5850 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: Tinted non-prescription spectacle lens
Optego by Optego Vision USA, 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
- Optego Vision USA, Inc.
Sources (1)
- FDA UDI db700aba-d785-438c-8c77-971d6b36b8bc 33 fields · synced Jun 7, 2026