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iTrack 250E iT-250E

by Nova Eye, 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 Number00893872001653 UDI-DI Date5 May 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  • Withdrawn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
iTrack 250E
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Model / Ref / Catalog
iT-250E, 202039
Primary DI / UDI-DI
00893872001653
FDA Product Code
HMX, MRH, MPA
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Device Class
Class I
Regulation Number
886.4350, 880.5725, 876.1500
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 250 Micrometer
Weight — 0.535 Pound
Length — 13.5 Centimeter

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No