Catalog Number

-

Brand Name

Uterine ElevatOR Pro

Version/Model Number

UE-TVPRO-40

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

-

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

b5b9fa7c-8e98-49b9-899f-6bc683bb0c42

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2018

Package DI Number

09349967002865

Quantity per Package

6

Contains DI Package

09349967002858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box