Catalog Number

FG70412JP

Brand Name

'CO2RE System, Packaged (Japan)

Version/Model Number

FG70412JP

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

K151655

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

53ff89d6-88e6-4e70-92ae-a55d2c0f4e14

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

August 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-