Catalog Number

-

Brand Name

DEFENDO Biopsy Valve Irrigator

Version/Model Number

100303

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

K110088,K110088,K110088

Product Code

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

789c919b-0a69-4ffc-a845-61e3f2250b0e

Public Version Date

April 27, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

20677964060285

Quantity per Package

50

Contains DI Package

00677964060281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case