AccessGUDID - DEVICE: iTrack 250A (00893872001059)

GUDID

Device Identifier (DI) Information

Brand Name: iTrack 250A
Version or Model: iTrack 250A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200478
Company Name: Nova Eye, Inc.

Primary DI Number: 00893872001059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079755637 *Terms of Use

Device Description: Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42572	Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic
MRH	Pump, Infusion, Ophthalmic
MPA	Endoilluminator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 250 Micrometer
Length: 12.5 Centimeter
Weight: 0.535 Pound

Device Record Status

Public Device Record Key: 099ce6e6-853e-4275-809e-e2c538f9da0b
Public Version Date: April 04, 2023
Public Version Number: 7
DI Record Publish Date: September 15, 2016