Catalog Number

-

Brand Name

andorate® 2-piece Valve Kit

Version/Model Number

GAR037C

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

-

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

951b1f7f-84a3-430d-847d-c02c37ad9006

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

14897106954039

Quantity per Package

50

Contains DI Package

04897106954032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box