Z Cartridge IOL Delivery System - Handpiece 003500-0047-252

GUDID 00843045101840

CARL ZEISS MEDITEC PRODUCTION, LLC

Manual intraocular lens injector, reusable

• Primary Device ID: 00843045101840
• NIH Device Record Key: d09c7745-bf0f-4916-bacb-083828b52264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z Cartridge IOL Delivery System - Handpiece
• Version Model Number: R28
• Catalog Number: 003500-0047-252
• Company DUNS: 080685425
• Company Name: CARL ZEISS MEDITEC PRODUCTION, LLC
• 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	00843045101840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123888

FDA Product Code

• MSS: Folders And Injectors, Intraocular Lens (Iol)

Sterilization

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

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

[00843045101840]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-10
• Device Publish Date: 2018-09-07

Devices Manufactured by CARL ZEISS MEDITEC PRODUCTION, LLC

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• 00843045101901 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +01.0D
• 00843045101918 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +01.5D
• 00843045101925 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +02.0D
• 00843045101932 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +02.5D
• 00843045101949 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +03.0D
• 00843045101956 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +03.5D