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Comfort Colors Gray / -01.00

by New York Optical-International, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number08101405700242 UDI-DIDate9 Aug 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Comfort Colors
Generic Name
Soft corrective contact lens, daily-wear
Model / Reference
Gray / -01.00
Primary DI / UDI-DI
08101405700242
FDA Product Code
LPL
GMDN Term
Soft corrective contact lens, daily-wear
Device Class
Class II
Regulation Number
886.5925
GUDID distribution status
Not in Commercial Distribution

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No