Catalog Number

-

Brand Name

ClearView Uterine Manipulator

Version/Model Number

UM700

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"

Yes

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

K940681,K940681,K940681

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

f194c860-332b-4940-9284-413dc08210d7

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020011

Quantity per Package

4

Contains DI Package

10814247020014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-