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Ernest Hemingway H4743-TOR-53

by New York Eye

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 Number00754317228748 UDI-DIDate17 Aug 2026ListedStatusListed 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  • Withdrawn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
Ernest Hemingway
Generic Name
Tinted non-prescription spectacle lens
Model / Reference
H4743-TOR-53
Primary DI / UDI-DI
00754317228748
FDA Product Code
HQY
GMDN Term
Tinted non-prescription spectacle lens
Device Class
Class I
Regulation Number
886.5850
GUDID distribution status
In Commercial Distribution

Other devices from New York Eye

See all devices from New York Eye →

Properties

  • Premarket Exempt

Other properties (13)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No