Catalog Number

-

Brand Name

Intrauterine insemination cannula

Version/Model Number

#4225 Smooze

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

aceda655-0ccd-4338-940a-5fe5ee4df6c0

Public Version Date

January 23, 2019

Public Version Number

5

DI Record Publish Date

January 17, 2017

Package DI Number

25425017502023

Quantity per Package

125

Contains DI Package

05425017502029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-