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Intraocular Lens

by Ophthamic Solution, Inc. 2 variants

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 31 May 2026. What this means

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840244500009 UDI-DI Date22 Oct 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Posterior-chamber intraocular lens, pseudophakic
Model / Reference
Intraocular Lens
Primary DI / UDI-DI
00840244500009
FDA Product Code
HQL
GMDN Term
Posterior-chamber intraocular lens, pseudophakic
Device Class
Class III
Regulation Number
886.3600
GUDID distribution status
In Commercial Distribution

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No