Catalog Number

-

Brand Name

PKS Plasma-Cise 5 Fr (1.67) Electrode/33cm

Version/Model Number

714500

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

K990628,K990628

Product Code

FDS

Product Code Name

Gastroscope and accessories, flexible/rigid

Public Device Record Key

d2f9d278-83a1-45c0-9743-f2ed5f5f9ac4

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

October 06, 2016

Package DI Number

00821925009868

Quantity per Package

5

Contains DI Package

00821925035959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-