Catalog Number

-

Brand Name

andorate® Disposable Endoscope Valves Set

Version/Model Number

GAR065

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"

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

06736e54-ab2b-4a84-863f-c5a14f21a0f0

Public Version Date

January 12, 2022

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

14897106952196

Quantity per Package

50

Contains DI Package

04897106952199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box