Catalog Number

-

Brand Name

WiScope®

Version/Model Number

OTU-100SR

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

Product Code

FGB

Product Code Name

Ureteroscope And Accessories, Flexible/Rigid

Public Device Record Key

c3c70e10-805e-43d3-9f10-3cf9b0797f72

Public Version Date

June 10, 2019

Public Version Number

2

DI Record Publish Date

January 10, 2019

Package DI Number

16972084140044

Quantity per Package

10

Contains DI Package

06972084140047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-