Identity
- Trade Name
- Superflex Titan FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- Spectacle Frame FDA UDI
- Model / Reference
- SF-1148T PERI LILAC FDA UDI
- Description
- Spectacle Frame FDA UDI
Identifiers
- Catalog Number
- SF1148TM2075416C FDA UDI
- Primary DI / UDI-DI
- 00676190648522 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
A comprehensive ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears.
Similar devices
Also classified as Spectacle frame.
- Fielmann — Fielmann Group AG · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- Fielmann — Fielmann Group AG · Class I
- EYEWEAR BY ROI WOODBURY BROWN — Eyewear By Roi, Limited · Class I
- 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 dd3818e0-bcca-41b8-b651-4c568f201a8c 35 fields · synced Jul 24, 2026