Catalog Number

-

Brand Name

Neoscope

Version/Model Number

NFU 9

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

K120766,K120766

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

8b172aec-da34-40d3-a35c-fe5521f1d90d

Public Version Date

April 22, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10851545007620

Quantity per Package

1

Contains DI Package

00851545007623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box