Catalog Number

GS-018C

Brand Name

J-PLASMA®

Version/Model Number

GS-018C

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

Yes

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

K112233,K112233

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5677c091-dc72-49a2-a946-dd9a50921aff

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10607151007819

Quantity per Package

6

Contains DI Package

00607151007812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX