Catalog Number

100319

Brand Name

DEFENDO Disposable Biopsy Valve

Version/Model Number

100319

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2022

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

K090851

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

c5d6abc1-274f-47ba-8f00-fb4f0b770b07

Public Version Date

May 26, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-