MICOR Vitrector

GUDID 00850005541042

Ophthalmic Anterior Vitrectomy Device

Carl Zeiss Meditec, Cataract Technology, Inc.

Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system Phacoemulsification system 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