HDX

GUDID 08806392040790

INTEROJO INC.

Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear

• Primary Device ID: 08806392040790
• NIH Device Record Key: 6b56ba62-6641-41f4-bfc6-f3b97268f7a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDX
• Version Model Number: HDX
• Company DUNS: 688455799
• Company Name: INTEROJO INC.
• Device Count: 6
• 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
• Phone: +1-760-754-2220
• Email: rho@interojo.com
• Phone: +1-760-754-2220
• Email: rho@interojo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806392040790 [Primary]
GS1	08806392040813 [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: 2020-02-11
• Device Publish Date: 2020-02-03

Devices Manufactured by INTEROJO INC.

• 08809981850015 - HAPA KRISTIN: 2023-11-27
• 08809981850022 - HAPA KRISTIN: 2023-11-27
• 08809981850039 - HAPA KRISTIN: 2023-11-27
• 08809981850046 - HAPA KRISTIN: 2023-11-27
• 08809981850053 - HAPA KRISTIN: 2023-11-27
• 08809981850060 - HAPA KRISTIN: 2023-11-27
• 08809981850077 - HAPA KRISTIN: 2023-11-27
• 08809981850084 - HAPA KRISTIN: 2023-11-27