Catalog Number

-

Brand Name

URETERO-RENO VIDEOSCOPE

Version/Model Number

OLYMPUS URF-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

K172246

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Public Device Record Key

3f04b8f0-9fb7-4373-8904-9464abbe782c

Public Version Date

September 05, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-