Catalog Number

-

Brand Name

VISERA ELITE XENON LIGHT SOURCE

Version/Model Number

OLYMPUS CLV-S190

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

K111425

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

34c3a9c8-2ffb-4326-bebc-ddc5fb714e9b

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-