Catalog Number

-

Brand Name

Uterine PositionOR

Version/Model Number

UE-POR

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

de5ce0b3-d1c3-4880-ac98-34238ccbf505

Public Version Date

March 04, 2022

Public Version Number

1

DI Record Publish Date

February 24, 2022

Package DI Number

09349967003091

Quantity per Package

8

Contains DI Package

09349967003084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer