Identity
- Trade Name
- Fysh Sunwear FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Sunglasses ( tinted non-prescription spectacles ) FDA UDI
- Model / Reference
- F-2117 BLACK TAUPE FDA UDI
- Description
- Sunglasses ( tinted non-prescription spectacles ) FDA UDI
Identifiers
- Catalog Number
- F2117S4004924C FDA UDI
- Primary DI / UDI-DI
- 00676190767421 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacles 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tinted non-prescription spectacles
Fysh Sunwear by WestGroupe Optical 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
- WestGroupe Optical Inc
Sources (1)
- FDA UDI 9f92014e-f58b-4e84-b43d-fc197e961c85 35 fields · synced May 29, 2026