Catalog Number

4101U0301T

Brand Name

WiScope®

Version/Model Number

OTU-100SL

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

d6e1419b-4ea9-4b1d-8491-2cd3ec058598

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 17, 2021

Package DI Number

10850023925067

Quantity per Package

10

Contains DI Package

00850023925060

Package Discontinue Date

April 17, 2021

Package Status

Not in Commercial Distribution

Package Type

-