iStent inject G2-M-IS

GUDID 00853704002203

Trabecular Micro-Bypass System

Glaukos Corporation

Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent

• Primary Device ID: 00853704002203
• NIH Device Record Key: 0d2ca507-6b9c-40de-a612-497457778fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iStent inject
• Version Model Number: G2-M-IS
• Catalog Number: G2-M-IS
• Company DUNS: 012835406
• Company Name: Glaukos Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com
• Phone: 949-367-9600
• Email: Quality@glaukos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853704002203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170043

FDA Product Code

• OGO: Intraocular Pressure Lowering Implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-12
• Device Publish Date: 2018-07-25

Devices Manufactured by Glaukos Corporation

• 00853704002449 - iStent Infinite: 2022-10-27 Trabecular Micro-Bypass System
• 00853704002470 - iStent infinite: 2022-10-13 Trabecular Micro-Bypass System
• 00853704002456 - iPRIME: 2022-05-23 Viscodelivery System
• 00853704002463 - iAccess: 2022-05-23 Trabecular Trephine
• 00853704002319 - iStent inject W: 2020-08-19 Trabecular Micro-Bypass System
• 00853704002005 - iStent: 2019-09-12 Trabecular Micro-bypass Stent System - Right
• 00853704002012 - iStent: 2019-09-12 Trabecular Micro-bypass stent system - Left
• 00853704002029 - iStent: 2019-09-12 Trabecular Micro-bypass Inserter