Identity
- Trade Name
- iTrack Advance FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
- Device Name
- Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector FDA UDI
- Model / Reference
- iTrack-ADS FDA UDI
- Description
- Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector FDA UDI
Identifiers
- Catalog Number
- 203000-0001 FDA UDI
- Primary DI / UDI-DI
- 00893872001622 FDA UDI
- 510(k) Number
- K221872 FDA UDI
- FDA Product Code
- HMX FDA UDIMPA FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 45 Millimeter FDA UDIOuter Diameter — 250 Micrometer FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
iTrack Advance by Nova Eye, Inc. — Class I — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nova Eye, Inc.
Sources (2)
- FDA UDI a5a37df0-492a-4c0d-8056-e1f72ce026e2 38 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026