Catalog Number

-

Brand Name

andorate® Four Chamber Polyp Trap

Version/Model Number

GAR023

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

CBC

Product Code Name

Bottle, Collection And Trap, Breathing System (Uncalibrated)

Public Device Record Key

8c85292a-139c-41d8-bbbe-8e6147050832

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Package DI Number

14897106953490

Quantity per Package

12

Contains DI Package

04897106953493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box