Catalog Number

-

Brand Name

LifeStyles Ultra Thin 40 ct Bowl

Version/Model Number

813356000279

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

K941258

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

e9189ee9-804f-45fb-aec2-8fabf144f182

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-