Identity
- Trade Name
- Blake Kuwahara FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- FLETCHER - Blue Horn - 48 * 22 - 145 FDA UDI
- Model / Reference
- Fletcher-Blu Hrn FDA UDI
- Description
- FLETCHER - Blue Horn - 48 * 22 - 145 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810110314412 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
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: Spectacle frame
This Blake Kuwahara device, also known as Fletcher-Blu Hrn, is an ophthalmic spectacle frame designed to hold a pair of lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame supported by the nose and ears, with side shields for added protection. The device can be sterilized and has not undergone prior use or implantation. The company, Fade To Grey Corp., is responsible for its manufacture and distribution.
Similar devices
Also classified as Spectacle frame.
- Fielmann — Fielmann Group AG · Class I
- BBIG — BBig B.V. · Class I
- Fysh — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- Fielmann — Fielmann Group AG · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fade To Grey Corp.
Sources (1)
- FDA UDI e1d94a0a-ee64-4858-a765-efdeca5ace64 34 fields · synced Jul 7, 2026