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

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

c1507004-8908-40f7-9d3f-a4658d390e87

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

10067981087274

Quantity per Package

9

Contains DI Package

00067981087277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton