iStent Infinite iS3-US

GUDID 00853704002449

Trabecular Micro-Bypass System

GLAUKOS CORPORATION

Glaucoma micro-stent

• Primary Device ID: 00853704002449
• NIH Device Record Key: 45c8e88f-dc26-4b81-9cce-590e53b27203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iStent Infinite
• Version Model Number: iS3
• Catalog Number: iS3-US
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853704002449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220032

FDA Product Code

• KYF: Implant, Eye Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [iStent Infinite]

• 00853704002470: Trabecular Micro-Bypass System
• 00853704002449: Trabecular Micro-Bypass System