MeniconZ (tisilfocon A) Red

GUDID 00192538901086

MENICON CO.,LTD.

Orthokeratology contact lens

• Primary Device ID: 00192538901086
• NIH Device Record Key: 440dab8b-fe85-4301-8cad-32a4fd85ac99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeniconZ (tisilfocon A) Red
• Version Model Number: Wine Red
• Company DUNS: 690680533
• Company Name: MENICON CO.,LTD.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192538901086 [Primary]

FDA Product Code

• MWL: Lens, Contact (Rigid Gas Permeable), Extended Wear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by MENICON CO.,LTD.

• 00192538901086 - MeniconZ (tisilfocon A) Red: 2023-06-19
• 00192538901086 - MeniconZ (tisilfocon A) Red: 2023-06-19
• 00192538951357 - ACUVUE Abiliti Overnight Therapeutic lenses for myopia management: 2022-02-02
• 00192538951364 - ACUVUE Abiliti overnight for myopia management with astigmatism: 2022-02-02
• 00192538901079 - Menicon Progent Large Diameter Contact Lens Case: 2021-10-04
• 00192538901017 - Deluxe Scleral Lens Kit: 2020-05-11
• 00192538901024 - Deluxe Kit: 2020-05-11
• 00192538901031 - Basic Scleral Lens Kit: 2020-05-11
• 00884465603064 - Miru 1day Menicon Flat Pack TC CP30: 2020-01-20