Catalog Number

-

Brand Name

RIDER

Version/Model Number

9859

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

K000408,K000408,K000408,K000408

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

60e50105-ed52-4260-a789-d327735c3422

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

August 26, 2019

Package DI Number

30070907298597

Quantity per Package

24

Contains DI Package

10070907298593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case