Catalog Number

000842

Brand Name

Bard Stoma Measuring Device

Version/Model Number

000842

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

6d242878-95d5-4402-8473-bc28610fec42

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

February 18, 2016

Package DI Number

20801741081143

Quantity per Package

36

Contains DI Package

10801741081146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX