Catalog Number

660007040

Brand Name

Hysterosalpingography (HSG) Catheter

Version/Model Number

660007040

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"

-

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

333bf83c-96b9-4251-9cd0-78a52f56ae08

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 16, 2017

Package DI Number

20886333001174

Quantity per Package

10

Contains DI Package

00886333001170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box