MICOR Vitrector

GUDID 00850005541042

Ophthalmic Anterior Vitrectomy Device

Carl Zeiss Meditec, Cataract Technology, Inc.

Phacoemulsification system

• Primary Device ID: 00850005541042
• NIH Device Record Key: e5df2f40-2780-4b72-a9fe-752db2e323b7
• Commercial Distribution Discontinuation: 2023-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MICOR Vitrector
• Version Model Number: FG-50829
• Company DUNS: 080125056
• Company Name: Carl Zeiss Meditec, Cataract Technology, Inc.
• Device Count: 2
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005541042 [Primary]
GS1	10850005541049 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200584

FDA Product Code

• MLZ: Vitrectomy, Instrument Cutter

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: 2023-08-07
• Device Publish Date: 2023-07-28

Devices Manufactured by Carl Zeiss Meditec, Cataract Technology, Inc.

• 30850005541074 - miLOOP reusable: 2024-09-09 Ophthalmic Instrument. Lens Fragmentation Device.
• 00850005541042 - MICOR Vitrector: 2023-08-07Ophthalmic Anterior Vitrectomy Device
• 00850005541042 - MICOR Vitrector: 2023-08-07 Ophthalmic Anterior Vitrectomy Device