Catalog Number

-

Brand Name

Uvision Hysteroscope Cable

Version/Model Number

20050

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181909,K181909

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

bc7b7057-fa92-4e46-ad8d-47b57a6b0557

Public Version Date

November 05, 2019

Public Version Number

2

DI Record Publish Date

May 30, 2019

Package DI Number

10853277008029

Quantity per Package

1

Contains DI Package

00853277008022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch