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L&K Biomed BluEX Surgical Illuminator BR06-0001S

by Lumitex, 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 Number00812432023072 UDI-DI Date11 Dec 2025ListedStatusListed 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  • Withdrawn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
L&K Biomed BluEX Surgical Illuminator
Generic Name
Open surgical site internal light
Model / Reference
BR06-0001S
Primary DI / UDI-DI
00812432023072
FDA Product Code
FDG
GMDN Term
Open surgical site internal light
Device Class
Class I
Regulation Number
876.4530
GUDID distribution status
In Commercial Distribution

Other devices from Lumitex, Inc.

See all devices from Lumitex, Inc. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No