MICOR drive

GUDID 30860000122376

Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector

IANTECH, INC.

Phacoemulsification system
Primary Device ID30860000122376
NIH Device Record Keyeed9a2ce-85ed-4070-abde-e97721134193
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICOR drive
Version Model NumberFG-50631
Company DUNS080125056
Company NameIANTECH, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com
Phone925-595-9817
Emailandy.rybold@zeiss.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000122375 [Primary]
GS130860000122376 [Package]
Contains: 00860000122375
Package: Corrugated Cardboard [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

[30860000122376]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-29

Devices Manufactured by IANTECH, INC.

10860000122365 - MICOR extractor2021-02-08 Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
30860000122376 - MICOR drive2021-02-08Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector
30860000122376 - MICOR drive2021-02-08 Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector
30860000122307 - miLOOP2019-07-12 Ophthalmic Instrument. Lens Fragmentation Device.
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