Catalog Number

-

Brand Name

WiScope®

Version/Model Number

OTU-C380RL

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

Yes

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

K181977,K181977,K181977,K181977

Product Code

FGB

Product Code Name

Ureteroscope And Accessories, Flexible/Rigid

Public Device Record Key

7c3f0e52-0921-4867-9a1c-0ec84f369d0d

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

January 22, 2020

Package DI Number

16972084140075

Quantity per Package

10

Contains DI Package

06972084140078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-