ACUVUE Abiliti overnight for myopia management with astigmatism

GUDID 00192538951364

MENICON CO.,LTD.

Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens

• Primary Device ID: 00192538951364
• NIH Device Record Key: 87d8c7ab-ce8a-41f7-8ed8-ae7cddb7bffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUVUE Abiliti overnight for myopia management with astigmatism
• Version Model Number: ACUVUE Abiliti
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192538951364 [Primary]

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

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: 2022-02-02
• Device Publish Date: 2022-01-25

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• 00192538951364 - ACUVUE Abiliti overnight for myopia management with astigmatism: 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