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ICON Handpiece PCI 40-1002

by Phoenix Clinical

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 Number00857253006019 UDI-DI Date3 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  • Withdrawn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
ICON Handpiece
Generic Name
Ophthalmic fundus camera
Model / Reference
PCI 40-1002
Primary DI / UDI-DI
00857253006019
FDA Product Code
HKI
GMDN Term
Ophthalmic fundus camera
Device Class
Class II
Regulation Number
886.1120
GUDID distribution status
In Commercial Distribution

Other devices from Phoenix Clinical

See all devices from Phoenix Clinical →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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