Identity
- Trade Name
- IRONMAN FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Model / Reference
- 10206154.FMR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00031568409431 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacles 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
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: Tinted non-prescription spectacles
Ironman by Fgx International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tinted non-prescription spectacles.
- Sunglasses — Taizhou YuanMing Glasses Co., Ltd · Class I
- TAVAT Eyewear — TAVAT EYEWEAR SRL · Class I
- RUNWAY SUNWEAR — Visual Eyes Eyewear, Inc. · Class I
- EYEVAN7285 — EYEVAN INC. · Class I
- EYEVAN — EYEVAN INC. · Class I
- Tahari — COLORS IN OPTICS LTD. · Class I
- MASTER PIECE — Q Eye Eyewear Corp · Class I
- Fielmann — Fielmann Group AG · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fgx International Inc.
Sources (1)
- FDA UDI 62ee77d9-e1bc-48d3-9a12-9517c66b4b60 33 fields · synced Jun 8, 2026