Catalog Number

-

Brand Name

andorate® 4-piece Valve Kit

Version/Model Number

GAR092

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 24, 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"

-

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

9131ea56-594e-457f-a106-0b3f257c259c

Public Version Date

April 25, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2021

Package DI Number

14897106950451

Quantity per Package

50

Contains DI Package

04897106950454

Package Discontinue Date

November 24, 2021

Package Status

Not in Commercial Distribution

Package Type

Box