Z Cartridge IOL Delivery System - Cartridge 003500-0047-251

GUDID 00843045101833

CARL ZEISS MEDITEC PRODUCTION, LLC

Intraocular lens-insertion cartridge

• Primary Device ID: 00843045101833
• NIH Device Record Key: f79a5af4-6873-4409-9994-ae1da6344221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z Cartridge IOL Delivery System - Cartridge
• Version Model Number: Z28
• Catalog Number: 003500-0047-251
• Company DUNS: 080685425
• Company Name: CARL ZEISS MEDITEC PRODUCTION, LLC
• Device Count: 10
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843045101833 [Primary]
GS1	00843045101857 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123888

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-09-07

Devices Manufactured by CARL ZEISS MEDITEC PRODUCTION, LLC

• 00843045101888 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +00.0D
• 00843045101895 - CT LUCIA: 2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +00.5D
• 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