Catalog Number

ZUTR162000

Brand Name

Zutron Medical

Version/Model Number

ZUTR162000

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

-

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

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

8a5efee5-d1c7-4a08-8ee3-df7a7adca808

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-