Catalog Number

8000.COM03

Brand Name

EVA, combined machine including Laser (SMA connector)

Version/Model Number

8000.COM03

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"

Yes

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

K190875

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

4e152986-1250-4c27-bd68-d266f8864d80

Public Version Date

October 14, 2019

Public Version Number

1

DI Record Publish Date

October 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-