Catalog Number

-

Brand Name

KY Intense Condoms

Version/Model Number

Condom

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040185,K040185,K040185,K040185

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

af2ed07f-b88a-475f-843b-af406d22a7ee

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

Package DI Number

10067981087250

Quantity per Package

3

Contains DI Package

00067981087253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton