Catalog Number

-

Brand Name

VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300

Version/Model Number

OLYMPUS OTV-S300

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202646

Product Code

FET

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

53a0cdc9-2b34-43ee-8c38-73400f17dd1e

Public Version Date

September 05, 2022

Public Version Number

6

DI Record Publish Date

June 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-