Catalog Number

-

Brand Name

VISERA ELITE II XENON LIGHT SOURCE

Version/Model Number

OLYMPUS CLV-S200-IR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 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

Yes

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

-

FDA Premarket Submission

K200542

Product Code

NWB

Product Code Name

Endoscope, accessories, narrow band spectrum

Public Device Record Key

97de7989-a288-4660-b814-d8b5af8469dc

Public Version Date

August 16, 2022

Public Version Number

3

DI Record Publish Date

March 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-