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ProGear FM89150

by Prestige Ameritech

ProGear FM89150 is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 24 Dec 2020 (UDI-DI 00852212003634), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852212003634 UDI-DI Date24 Dec 2020ListedStatusListed 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  • Withdrawn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
ProGear
Generic name
Eye splash shield, single-use
Model / reference
FM89150
Primary DI / UDI-DI
00852212003634
FDA product code
HOY
GMDN term
Eye splash shield, single-use
Device class
Class I
Regulation number
886.4750
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)