Catalog Number

000843

Brand Name

Bard Stoma Measuring Device

Version/Model Number

000843

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

57377276-8f13-4767-8acf-efa0cd40aff8

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

10801741086844

Quantity per Package

5

Contains DI Package

00801741086847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA