Catalog Number

-

Brand Name

Andorate PearlCatch Single Chamber Polyp Trap

Version/Model Number

GAR014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2019

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)

-

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

09668774-84f5-48be-b886-d40b5e90ddcb

Public Version Date

October 27, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2018

Package DI Number

26970934720153

Quantity per Package

6

Contains DI Package

16970934720156

Package Discontinue Date

November 19, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton