Catalog Number

OS-CP 05-12H

Brand Name

PlasmaJet Neutral Plasma Surgery System

Version/Model Number

OS-CP 05-12H

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

83bdc04c-0307-42e6-9465-61a588868cf3

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

July 18, 2016

Package DI Number

M397OSCP0512H2

Quantity per Package

5

Contains DI Package

M3970SCP0512H0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX