Catalog Number

-

Brand Name

Intrauterine insemination cannula

Version/Model Number

#4220 Plus

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

3dae5c62-9fc4-4aa5-89b8-fc983f8d70bd

Public Version Date

January 23, 2019

Public Version Number

5

DI Record Publish Date

January 17, 2017

Package DI Number

15425017502088

Quantity per Package

25

Contains DI Package

05425017502081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-