MICOR extractor

GUDID 10860000122365

Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.

IANTECH, INC.

Phacoemulsification system

• Primary Device ID: 10860000122365
• NIH Device Record Key: 950eb7cd-38a1-47d1-8341-09b3335aa9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICOR extractor
• Version Model Number: FG-50621
• Company DUNS: 080125056
• Company Name: IANTECH, INC.
• Device Count: 5
• DM Exempt: true
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com
• Phone: 925-595-9817
• Email: andy.rybold@zeiss.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000122368 [Primary]
GS1	10860000122365 [Unit of Use]
GS1	30860000122369 [Package]; Contains: 00860000122368; Package: Corrugated Cardboard [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200584

FDA Product Code

• HQC: Unit, Phacofragmentation

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: 2021-02-08
• Device Publish Date: 2021-01-29

Devices Manufactured by IANTECH, INC.

• 10860000122365 - MICOR extractor: 2021-02-08Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
• 10860000122365 - MICOR extractor: 2021-02-08 Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
• 30860000122376 - MICOR drive: 2021-02-08 Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector
• 30860000122307 - miLOOP: 2019-07-12 Ophthalmic Instrument. Lens Fragmentation Device.