Catalog Number

I-IUI-O

Brand Name

Insemina Open Tip Intra Uterine Insemination Catheter

Version/Model Number

Insemina Open Tip

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

K190522,K190522

Product Code

MFD

Product Code Name

Cannula, Intrauterine Insemination

Public Device Record Key

d0b18b0f-a0a4-4e33-b053-a02c72b9ec30

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10819374021811

Quantity per Package

25

Contains DI Package

00819374021814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-