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iCE Surgical Light iCE30m

by Amico Clinical Solutions Corp 490 variants

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 Number00684706009859 UDI-DI Date16 Apr 2026ListedStatusListed 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  • Withdrawn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
iCE Surgical Light
Generic Name
Operating room light
Model / Ref / Catalog
iCE30m, SL-30M-GENE-DUAL-YOK-ASY
Description
SURGICAL LIGHT HEAD WITH DUAL YOKE ASSEMBLY - GENE-5P SURGICAL LIGHT HEAD WITH DUAL YOKE ASSEMBLY - GENE-9P (CAMERA)
Primary DI / UDI-DI
00684706009859
FDA Product Code
FSY
GMDN Term
Operating room light
Device Class
Class II
Regulation Number
878.4580
GUDID distribution status
In Commercial Distribution

Other devices from Amico Clinical Solutions Corp

See all devices from Amico Clinical Solutions Corp →

Properties

  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No