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StarTrol 8X4-GS2

by Huot Instruments, LLC

StarTrol 8X4-GS2 is a fixed examination/treatment room light (FDA Class II) made by Huot Instruments, LLC, listed in FDA GUDID since 9 Feb 2017 (UDI-DI M5758X4GS20), 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 NumberM5758X4GS20 UDI-DI Date9 Feb 2017ListedStatusListed 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  • Withdrawn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
StarTrol
Generic name
Fixed examination/treatment room light
Model / Ref / Catalog
8X4-GS2
Primary DI / UDI-DI
M5758X4GS20
FDA product code
FSY, FTD, KZF, FSS
GMDN term
Fixed examination/treatment room light
Device class
Class II
Regulation number
878.4580, 880.6320
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Fixed examination/treatment room lightMobile examination/treatment room light

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Other devices filed under Mobile examination/treatment room light.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)