Catalog Number

-

Brand Name

DEFENDO SINGLE USE VALVE KIT

Version/Model Number

100322

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

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

3dab36fc-89bb-43be-b017-98744ebce33e

Public Version Date

April 27, 2022

Public Version Number

10

DI Record Publish Date

June 04, 2019

Package DI Number

40677964009998

Quantity per Package

50

Contains DI Package

00677964092992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-