Catalog Number

-

Brand Name

WiScope®

Version/Model Number

OTU-C300S

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

K212202,K212202,K212202

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

a14218f3-b901-407c-abdc-427a92a3f54c

Public Version Date

April 26, 2022

Public Version Number

1

DI Record Publish Date

April 18, 2022

Package DI Number

10850023925166

Quantity per Package

2

Contains DI Package

00850023925169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-