Catalog Number

-

Brand Name

RIDER

Version/Model Number

9857

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,K941258,K941258,K941258

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

dad6819c-609c-4fde-8d2d-859f5cd83387

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

August 26, 2019

Package DI Number

30070907298573

Quantity per Package

24

Contains DI Package

10070907298579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case