Catalog Number

-

Brand Name

URETERO-RENO VIDEOSCOPE

Version/Model Number

OLYMPUS URF-V3

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

K181451

Product Code

FBN

Product Code Name

Choledochoscope and accessories, flexible/rigid

Public Device Record Key

fb73ef88-1154-430a-bba6-2a5cb7a359e2

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-