iStent GTS100L

GUDID 00853704002012

Trabecular Micro-bypass stent system - Left

Glaukos Corporation

Glaucoma micro-stent

• Primary Device ID: 00853704002012
• NIH Device Record Key: 764a1b82-b9a0-44ed-a94b-047e5d1c8a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iStent
• Version Model Number: GTS100L
• Catalog Number: GTS100L
• 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
• 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	00853704002012 [Primary]

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: 3
• Public Version Date: 2019-09-12
• Device Publish Date: 2015-09-21

On-Brand Devices [iStent]

• 00853704002029: Trabecular Micro-bypass Inserter
• 00853704002012: Trabecular Micro-bypass stent system - Left
• 00853704002005: Trabecular Micro-bypass Stent System - Right