iPRIME VCP100

GUDID 00853704002456

Viscodelivery System

GLAUKOS CORPORATION

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 00853704002456
• NIH Device Record Key: 58649cac-1652-44b4-9e41-2595033b8b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iPRIME
• Version Model Number: VCP100
• Catalog Number: VCP100
• Company DUNS: 012835406
• Company Name: GLAUKOS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853704002456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212797

FDA Product Code

• MRH: Pump, Infusion, Ophthalmic

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: 2022-05-23
• Device Publish Date: 2022-05-13

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: 2022-05-23Viscodelivery 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