Sophisticated Kristin Monthly

GUDID 08800071420378

Sophisticated Kristin Monthly/Olive Color/-2.25/100EA

DK MEDIVISION Co.,Ltd.

Soft corrective contact lens, daily-wear

• Primary Device ID: 08800071420378
• NIH Device Record Key: a6792db8-df7d-4fd7-9a56-d3cb0f8fc13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sophisticated Kristin Monthly
• Version Model Number: Sophisticated Kristin Monthly
• Company DUNS: 688303758
• Company Name: DK MEDIVISION Co.,Ltd.
• Device Count: 100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800071415251 [Primary]
GS1	08800071420378 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220045

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: 2025-06-17
• Device Publish Date: 2025-06-09

On-Brand Devices [ Sophisticated Kristin Monthly]

• 08800071420446: Sophisticated Kristin Monthly/Olive Color/-4.00/100EA
• 08800071420378: Sophisticated Kristin Monthly/Olive Color/-2.25/100EA