Catalog Number

-

Brand Name

URETERO-RENO FIBERSCOPE

Version/Model Number

OLYMPUS URF-P6

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

K172298

Product Code

FBN

Product Code Name

Choledochoscope And Accessories, Flexible/Rigid

Public Device Record Key

f552d2ae-cde8-4df3-9204-9fdbffd3d1dc

Public Version Date

September 17, 2020

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

-