Catalog Number

-

Brand Name

andorate® Disposable Biopsy Valve

Version/Model Number

GAR018

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 06, 2021

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"

Yes

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

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

42035959-2736-4928-a5c0-d56e323bdf96

Public Version Date

March 02, 2022

Public Version Number

4

DI Record Publish Date

August 05, 2020

Package DI Number

14897106950390

Quantity per Package

100

Contains DI Package

04897106950393

Package Discontinue Date

January 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Box