MICOR Auto I/A

GUDID 00850005541080

MICOR Automatic Irrigation Device

Carl Zeiss Meditec, Cataract Technology, Inc.

Phacoemulsification/vitrectomy system

• Primary Device ID: 00850005541080
• NIH Device Record Key: 254f025a-81ab-4c67-a368-a68b62ed118a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICOR Auto I/A
• Version Model Number: FG-51820
• Company DUNS: 080125056
• Company Name: Carl Zeiss Meditec, Cataract Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com
• Phone: 775-473-1014
• Email: qualitycti.med.us@zeiss.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005541080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243395

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-27
• Device Publish Date: 2025-08-19

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

• 00850005541080 - MICOR Auto I/A: 2025-08-27MICOR Automatic Irrigation Device
• 00850005541080 - MICOR Auto I/A: 2025-08-27 MICOR Automatic Irrigation Device
• 30850005541074 - miLOOP reusable: 2024-09-09 Ophthalmic Instrument. Lens Fragmentation Device.
• 00850005541042 - MICOR Vitrector: 2023-08-07 Ophthalmic Anterior Vitrectomy Device