Catalog Number

-

Brand Name

EVIS EXERA DUODENOVIDEOSCOPE

Version/Model Number

OLYMPUS PJF TYPE 160

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K954451

Product Code

FET

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

3fd9a3ed-8e6d-4c6a-9114-aec0805a4bd9

Public Version Date

August 10, 2022

Public Version Number

2

DI Record Publish Date

March 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-