MICOR Auto I/A

Basic Information

• Brand Name: MICOR Auto I/A
• Primary DI: 00850005541080
• Version / Model: FG-51820
• Company Name: Carl Zeiss Meditec, Cataract Technology, Inc.
• Labeler DUNS: 080125056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-19
• Public Version: 1
• Public Version Date: 2025-08-27
• Public Version Status: New
• Public Device Record Key: 254f025a-81ab-4c67-a368-a68b62ed118a

Device Description

MICOR Automatic Irrigation Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQC	Unit, Phacofragmentation	Ophthalmic	886.4670	2
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45072	Phacoemulsification/vitrectomy system	An assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850005541080	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243395	000