Catalog Number

-

Brand Name

andorate® Disposable Biopsy Valve

Version/Model Number

GAR018-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 25, 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

12a4b06a-f199-4c45-86d6-9be0ac7e9df2

Public Version Date

April 25, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2020

Package DI Number

14897106950376

Quantity per Package

100

Contains DI Package

04897106950379

Package Discontinue Date

June 25, 2021

Package Status

Not in Commercial Distribution

Package Type

Box