Catalog Number

-

Brand Name

Disposable Four-Chamber Polyp Trap

Version/Model Number

EN10103.4

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)

-

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

e6a327fc-e445-43b3-825c-4d18edea24aa

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

14897106955067

Quantity per Package

12

Contains DI Package

04897106955060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box