Catalog Number

-

Brand Name

VISERA ELITE II VIDEO SYSTEM CENTER

Version/Model Number

OLYMPUS OTV-S200

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

K190449

Product Code

FET

Product Code Name

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Public Device Record Key

359213ed-43e4-42dd-99f6-f63be2f95af6

Public Version Date

June 22, 2022

Public Version Number

3

DI Record Publish Date

December 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-