AccessGUDID - DEVICE: iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology (00853704002487)

GUDID

Device Identifier (DI) Information

Brand Name: iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology
Version or Model: iS2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: iS2
Company Name: GLAUKOS CORPORATION

Primary DI Number: 00853704002487
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012835406 *Terms of Use

Device Description: Trabecular Micro-Bypass System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
Over the Counter (OTC):	No
Kit:	No
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?
62945	Glaucoma micro-stent	A non-bioabsorbable device designed to be implanted in Schlemm’s canal (within the eye) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. It is a metallic device which may be intended to dilate, support, and/or create a channel into Schlemm’s canal; disposable devices associated with implantation (e.g., delivery system) may be packaged with the stent.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OGO	Intraocular Pressure Lowering Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170043	019

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef61219a-8d13-4202-8b03-217fbc17860f
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: April 30, 2025