Catalog Number

-

Brand Name

Lifestyles

Version/Model Number

2028

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163107,K163107,K163107,K163107

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

39a6ecd7-bf38-4326-a567-348c773a1934

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2018

Package DI Number

30070907220284

Quantity per Package

6

Contains DI Package

10070907220280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case