Catalog Number

S-CDU-12

Brand Name

PlasmaJet Neutral Plasma Surgery System

Version/Model Number

S-CDU+12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K121977,K121977

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5d39352d-071f-4fc7-beff-098ce7e2070a

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

October 01, 2018

Package DI Number

M397SCDU122

Quantity per Package

5

Contains DI Package

M397SCDU120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box