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Gallery JSSETO54

by Kenmark Optical Co., 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00715317129183 UDI-DI Date12 Aug 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  • Withdrawn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

Trade name
Gallery
Generic name
Prescription spectacles
Model / reference
JSSETO54
Primary DI / UDI-DI
00715317129183
FDA product code
HQZ
GMDN term
Prescription spectacles
Device class
Class I
Regulation number
886.5842
GUDID distribution status
In Commercial Distribution

Related devices

Category: Prescription spectacles

Other devices from Kenmark Optical Co., Inc.

See all devices from Kenmark Optical Co., Inc. →

Properties

  • Over-the-counter
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: 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