PolyVue

GUDID 08806392051116

INTEROJO INC.

Soft corrective contact lens, daily-wear

• Primary Device ID: 08806392051116
• NIH Device Record Key: 753f939f-e5cb-4b80-8c1e-f568e1fbb59d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyVue
• Version Model Number: High Definition
• Company DUNS: 688455799
• Company Name: INTEROJO INC.
• Device Count: 4
• 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: false
• 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: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806392051062 [Primary]
GS1	08806392051116 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020608

FDA Product Code

• LPL: Lenses, Soft Contact, Daily Wear

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: 2020-09-15
• Device Publish Date: 2020-09-07

On-Brand Devices [PolyVue]

• 08806392051123: HDX Progressive
• 08806392050171: HD pro color/Turquoise
• 08806392050164: HD pro color/True Sapphire
• 08806392050157: HD pro color/Pure Hazel
• 08806392050140: HD pro color/Honey
• 08806392050133: HD pro color/HAZEL
• 08806392050126: HD pro color/GREEN
• 08806392050119: HD pro color/GRAY
• 08806392050102: HD pro color/Brown
• 08806392050096: HD pro color/Amethyst
• 08806392051116: High Definition
• 08800190057301: HD pro color/Zombie Red
• 08800190057295: HD pro color/Wild Fire
• 08800190057288: HD pro color/Red Cat
• 08809867730349: HD pro color /Yellow Cat
• 08809867730325: HD pro color /Zombie Black
• 08800143688910: HD pro color/White Out
• 08809901666757: Clalen / -06.00
• 08809901666740: Clalen / -04.00
• 08809901666733: Clalen / +02.75