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SurgiTel Wireless LED Headlight

by Surgitel

SurgiTel Wireless LED Headlight is a Class I device made by Surgitel, listed in FDA GUDID since 12 Jan 2023 (UDI-DI 00810114912034), 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 Number00810114912034 UDI-DI Date12 Jan 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  • Withdrawn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
SurgiTel
Generic name
Operating room light
Model / reference
Wireless LED Headlight
Primary DI / UDI-DI
00810114912034
FDA product code
KYT
GMDN term
Operating room light
Device class
Class I
Regulation number
880.6350
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KYT (Light, Examination, Medical, Battery Powered).

Other devices from Surgitel

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Properties

  • Premarket exempt
Other properties (14, all answered No)