iStent inject

Basic Information

• Brand Name: iStent inject
• Primary DI: 00853704002203
• Version / Model: G2-M-IS
• Catalog Number: G2-M-IS
• Company Name: GLAUKOS CORPORATION
• Labeler DUNS: 012835406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-25
• Public Version: 4
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 0d2ca507-6b9c-40de-a612-497457778fed

Device Description

Trabecular Micro-Bypass System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGO	Intraocular Pressure Lowering Implant	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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 included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853704002203	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P170043	000