HDX2

GUDID 08806392040097

INTEROJO INC.

Soft corrective contact lens, daily-wear

• Primary Device ID: 08806392040097
• NIH Device Record Key: 60802446-5ddc-4777-91f3-64dbd970e010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDX2
• Version Model Number: HDX2
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806392040097 [Primary]
GS1	08806392040219 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080794

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.

• 08809752409763 - HAPA KRISTIN: 2025-04-28
• 08809752409770 - HAPA KRISTIN: 2025-04-28
• 08809752409787 - HAPA KRISTIN: 2025-04-28
• 08809752409794 - HAPA KRISTIN: 2025-04-28
• 08800245547405 - Miz: 2024-10-02
• 08800245547412 - Miz: 2024-10-02
• 08800245547429 - Miz: 2024-10-02
• 08800245547436 - Miz: 2024-10-02