Catalog Number

-

Brand Name

DEFENDO Air/Water/Suction and Biopsy Valve

Version/Model Number

100305

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

K102581,K090851,K102409,K102581,K090851,K102409,K102581,K090851,K102409

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

83b4a175-c52b-44b8-a16c-75fe1902272c

Public Version Date

April 27, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

20677964060254

Quantity per Package

100

Contains DI Package

00677964060250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case