Catalog Number

-

Brand Name

Polyp Trap

Version/Model Number

MD-A-PT70

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

b5e66b98-5bbf-4f3f-ae66-21f46bd43814

Public Version Date

July 18, 2022

Public Version Number

6

DI Record Publish Date

June 10, 2019

Package DI Number

26970401814224

Quantity per Package

8

Contains DI Package

16970401814012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case