Model: iT-250E
Catalog: 202039
DI: 00893872001653
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-28
Description
Canaloplasty Microcatheter Kit
Kit Contents:
(1) Canaloplasty Microcatheter iTrack 250E
(1) Ophthalmic ViscoInjector
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
2f03ce37-5f55-4ba6-bec7-7fb98c7b4896
Distribution Status:
In Commercial Distribution
DUNS Number:
079755637
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00893872001653
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 42572
Name: Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Definition:
A hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to infuse, irrigate and/or aspirate the interior of the eye during a surgical procedure (e.g., cataract extraction), and simultaneously conduct, typically via a fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the infusion/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device.
FDA Product Codes
HMX
Cannula, Ophthalmic
MRH
Pump, Infusion, Ophthalmic
MPA
Endoilluminator
Device Sizes
Item #1 - Size - @attributes - Unit:
Micrometer
Item #1 - Size - @attributes - Value:
250
Item #1 - Size Type:
Outer Diameter
Item #2 - Size - @attributes - Unit:
Pound
Item #2 - Size - @attributes - Value:
0.535
Item #2 - Size Type:
Weight
Item #3 - Size - @attributes - Unit:
Centimeter
Item #3 - Size - @attributes - Value:
13.5
Item #3 - Size Type:
Length
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature