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ICU Eyewear 75291808

by Zoom Eyeworks Dba ICU Eyewear, 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 Number00078041189473 UDI-DI Date29 Nov 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  • Withdrawn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
ICU Eyewear
Generic Name
Magnifying spectacles
Model / Reference
75291808
Primary DI / UDI-DI
00078041189473
FDA Product Code
HOI
GMDN Term
Magnifying spectacles
Device Class
Class I
Regulation Number
886.5840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Magnifying spectacles

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Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No