Identity
- Trade Name
- iTrack 250A EUDAMEDFDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
- Device Name
- Canaloplasty Microcatheter Kit EUDAMEDCanaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector FDA UDI
- Model / Reference
- iT-250A EUDAMEDiTrack 250A FDA UDI
- Description
- Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector FDA UDI
Identifiers
- Catalog Number
- 200478 FDA UDI
- Primary DI / UDI-DI
- 00893872001059 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00893872001059 EUDAMED0893872001iT-250AKE EUDAMED
- FDA Product Code
- HMX FDA UDIMRH FDA UDIMPA FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI880.5725 FDA UDI876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Outer Diameter — 250 Micrometer FDA UDILength — 12.5 Centimeter FDA UDIWeight — 0.535 Pound FDA UDI
iTrack 250A by Nova Eye, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00893872001059 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00893872001059 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nova Eye, Inc.
- EUDAMED SRN
- US-MF-000011341
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 82e37ebc-b88a-48de-87f9-0672985f1574 61 fields · synced Jun 19, 2026
- EUDAMED e83d7f8b-08fd-4b13-a34f-cfd9b93ae267 61 fields · synced May 17, 2026
- FDA UDI 099ce6e6-853e-4275-809e-e2c538f9da0b 37 fields · synced May 30, 2026