Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

944705

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

d34c736f-ddb0-450f-970a-e0206719fab2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 23, 2018

Package DI Number

M7529447055

Quantity per Package

10

Contains DI Package

M7529447051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box