Catalog Number

-

Brand Name

KY Extra Lubricated 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

K980319,K980319,K980319,K980319

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

dac44ca1-0d13-480f-a6f0-d4890952b179

Public Version Date

May 20, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2018

Package DI Number

20067981087189

Quantity per Package

6

Contains DI Package

10067981087182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case