Monarch

GUDID 00380659777745

Clareon Monarch IV IOL Delivery System for use with Clareon only

Alcon Laboratories, Inc.

Manual intraocular lens injector, reusable

• Primary Device ID: 00380659777745
• NIH Device Record Key: ebb85223-16bd-4767-882b-5fbbb6c50f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch
• Version Model Number: 00380659777745
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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: true
• Manufacturing Date: true
• 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	00380659777745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212039

FDA Product Code

• MSS: Folders and injectors, intraocular lens (iol)

Sterilization

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

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

[00380659777745]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-19
• Device Publish Date: 2021-11-11

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• 00380652399616 - Clareon: 2025-12-04 CLAREON TORIC AUTONOME
• 00380652399623 - Clareon: 2025-12-04 CLAREON TORIC AUTONOME
• 00380652399630 - Clareon: 2025-12-04 CLAREON TORIC AUTONOME