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

ff565f79-85cc-4bd4-890f-d2bb5fd6cb9f

Public Version Date

June 20, 2019

Public Version Number

1

DI Record Publish Date

June 12, 2019

Package DI Number

10067981087755

Quantity per Package

6

Contains DI Package

00067981087758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton