Catalog Number

-

Brand Name

VISERA CYSTO-NEPHRO VIDEOSCOPE

Version/Model Number

OLYMPUS CYF TYPE V2R

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

K133538

Product Code

NWB

Product Code Name

Endoscope, accessories, narrow band spectrum

Public Device Record Key

caee2631-d3b7-45b2-96ad-5471a1b5a15d

Public Version Date

September 05, 2022

Public Version Number

3

DI Record Publish Date

July 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-