MICOR extractor

GUDID 10860000122365

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

IANTECH, 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 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 Phacoemulsification system 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.