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Optego 97836

by Optego Vision USA, Inc.

Optego 97836 is a Class I device made by Optego Vision USA, Inc., listed in FDA GUDID since 10 Nov 2023 (UDI-DI 00360843009395), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00360843009395 UDI-DI Date10 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Optego
Generic name
Eye patch, single-use
Model / reference
97836
Primary DI / UDI-DI
00360843009395
FDA product code
HOY
GMDN term
Eye patch, single-use
Device class
Class I
Regulation number
886.4750
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)