Identity
- Trade Name
- BBIG FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- TR06245206 FDA UDI
- Model / Reference
- TR06245206 FDA UDI
- Description
- TR06245206 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719616034058 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
Yes
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
This BBIG device is designed to hold a pair of spectacle lenses in front of and close to the eyes of the user, typically consisting of a plastic or metallic frame supported by the nose and ears. It may also include protective functions such as side shields. The device has undergone regulatory approval and commercial distribution.
Similar devices
Also classified as Spectacle frame.
- Fielmann — Fielmann Group AG · Class I
- Fysh — WestGroupe Optical Inc · Class I
- Kliik:denmark Eyewear — WestGroupe Optical Inc · 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
- Kazuo Kawasaki — MASUNAGA OPTICAL MFG.CO., LTD. · Class I
- Superflex Kids Collection — WestGroupe Optical Inc · 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
- BBig B.V.
Sources (1)
- FDA UDI 4bcb34be-c11c-4466-a4e4-cb8b35e23e09 33 fields · synced Jul 1, 2026