Identity
- Trade Name
- Fysh Sunwear FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Model / Reference
- F-2046 PURPLE SHIMMER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00676190417807 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Spectacle frame 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Tinted non-prescription spectaclesSpectacle frame
Discover the Fysh Sunwear, a stylish and safe ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of users. With its sleek plastic or metallic frame and protective side shields, this device provides a comfortable and secure fit for glasses wearers. As an implantable-free device, it's perfect for anyone looking for a convenient and hassle-free way to protect their vision.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 63f17c4c-f0a6-4617-870b-2c84d03d1a07 32 fields · synced Oct 6, 2026