Catalog Number

-

Brand Name

Intrauterine insemination cannula

Version/Model Number

#4220 IUI

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

K013501,K013501,K013501

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

7dbd879a-497e-484c-9485-aa5b8da6a3c4

Public Version Date

January 23, 2019

Public Version Number

5

DI Record Publish Date

November 03, 2016

Package DI Number

25425017502009

Quantity per Package

125

Contains DI Package

05425017502005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-