iTrack 250A
Basic Information
- Primary DI
- 00893872001059
- Basic UDI-DI Code
- B-00893872001059
- Reference
- iT-250A
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Nova Eye, Inc.
Additional Description
The Nova Eye Canaloplasty Microcatheter Kit (iTrackโข 250A) consists of an illuminated, flexible microcatheter and Ophthalmic Viscoinjectorโข. The Canaloplasty Microcatheter is a flexible microcatheter design for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The ophthalmic ViscoInjectorโข is a manually operated device for precision delivery of small amounts of viscous fluid such as sterile viscoelastic solution in a cartridge. The device are provided sterile and are intended for single use. The iTrackโข 250A is designed to work with the Nova Eye iLuminโข Fiberoptic Illuminator.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q0299 | OPHTHALMIC DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41315215 | INTERTEK SEMKO AB | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).