Catalog Number

-

Brand Name

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

Version/Model Number

714510

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

-

Product Code

FDS

Product Code Name

Gastroscope and accessories, flexible/rigid

Public Device Record Key

8a3e612d-1e86-450d-a49a-85536d4d5f66

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

September 13, 2018

Package DI Number

00821925010499

Quantity per Package

5

Contains DI Package

00821925035966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-