Catalog Number

-

Brand Name

ManipulatOR

Version/Model Number

UM-TV

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

dec33cd9-6c03-4533-935d-27153f744def

Public Version Date

March 27, 2019

Public Version Number

1

DI Record Publish Date

March 19, 2019

Package DI Number

09349967003121

Quantity per Package

5

Contains DI Package

09349967003114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer