Catalog Number

-

Brand Name

MICOR drive

Version/Model Number

FG-50631

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200584,K200584

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

eed9a2ce-85ed-4070-abde-e97721134193

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Package DI Number

30860000122376

Quantity per Package

6

Contains DI Package

00860000122375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Cardboard