Skip to content

Ironman 10253543.COM

by Fgx International Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193033485972 UDI-DI Date22 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ironman
Generic name
Non-prescription sunglasses
Model / reference
10253543.COM
Primary DI / UDI-DI
00193033485972
FDA product code
HQY
GMDN term
Non-prescription sunglasses
Device class
Class I
Regulation number
886.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tinted non-prescription spectacles

Other devices from Fgx International Inc.

See all devices from Fgx International Inc. →

Properties

  • Premarket exempt

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: 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
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No