Catalog Number

0160-6020

Brand Name

CATALYS SYSTEM

Version/Model Number

Catalys Precision Laser System

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

-

Product Code

OOE

Product Code Name

Ophthalmic femtosecond laser

Public Device Record Key

2219d84c-1608-44b4-9ed5-0d589ef3b462

Public Version Date

October 26, 2020

Public Version Number

5

DI Record Publish Date

April 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-