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iTrack Advance iTrack-ADS

by Nova Eye, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00893872001684 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iTrack Advance
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Model / Ref / Catalog
iTrack-ADS, 203001-0001
Description
Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector
Primary DI / UDI-DI
00893872001684
510(k) Number
FDA Product Code
HMX, MPA
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Device Class
Class I
Regulation Number
886.4350, 876.1500
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 45 Millimeter
Outer Diameter — 250 Micrometer

Related devices

Cleared under the same submission (K221872)

Other devices from Nova Eye, Inc.

See all devices from Nova Eye, Inc. →

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