Identity
- Trade Name
- Fysh FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Model / Reference
- F-3620 CRYSTAL PALLA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00676190355741 FDA UDI
- FDA Product Code
- HQZ FDA UDI
- GMDN Term
- Spectacle frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5842 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: Spectacle frame
The Fysh device, a cutting-edge ophthalmic solution, is designed to hold pairs of spectacle lenses in front of and close to the eyes of the user. Consisting of a plastic or metallic frame supported by the nose and ears, this device provides a comfortable and secure fit for users.
Similar devices
Also classified as Spectacle frame.
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- Daniel Hechter — MPG GmbH · 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
- WestGroupe Optical Inc
Sources (1)
- FDA UDI 958de5ca-84e8-4889-8c09-f3035f795147 32 fields · synced Jul 24, 2026