Catalog Number

-

Brand Name

andorate® Click4Catch™ Click into Place Polyp Trap with Four Removable Capture C

Version/Model Number

GAR082

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

a69b8226-6f58-4e86-a836-74f2b75f8c0d

Public Version Date

January 11, 2022

Public Version Number

2

DI Record Publish Date

March 12, 2021

Package DI Number

14897106953513

Quantity per Package

12

Contains DI Package

04897106953516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box