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HarmonyAIR G-Series Surgical Lighting System

by Steris Corporation 140 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00724995167219 UDI-DI Date20 May 2020ListedStatusListed GUDID: not 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  • Withdrawn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
HarmonyAIR
Generic Name
Operating room light
Model / Ref / Catalog
G-Series Surgical Lighting System, LGH25N
Primary DI / UDI-DI
00724995167219
FDA Product Code
FSY
GMDN Term
Operating room light
Device Class
Class II
Regulation Number
878.4580
GUDID distribution status
Not in Commercial Distribution

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No