Menicon Unique pH Multi-Purpose Solution

GUDID 00853253003058

MENICON AMERICA, INC.

Multi-purpose rigid contact lens solution

• Primary Device ID: 00853253003058
• NIH Device Record Key: 958c80aa-a8da-4bfe-8047-315fe3ca04b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Menicon Unique pH Multi-Purpose Solution
• Version Model Number: Starter Kit
• Company DUNS: 034212507
• Company Name: MENICON AMERICA, INC.
• 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: 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	00853253003058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130805

FDA Product Code

• MRC: Products, Contact Lens Care, Rigid Gas Permeable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2016-09-23

On-Brand Devices [Menicon Unique pH Multi-Purpose Solution]

• 00853253003065: Travel Pack
• 00853253003058: Starter Kit
• 00853253003003: 120mL