Catalog Number

-

Brand Name

External Marker Cover A

Version/Model Number

MAJ-997

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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

K002749

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

da8697bb-98a7-4ab5-b55e-4b74b68916f9

Public Version Date

August 10, 2022

Public Version Number

2

DI Record Publish Date

December 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-