Catalog Number

-

Brand Name

Handy Solutions

Version/Model Number

26101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2019

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)

-

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

K033076

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

d22b4153-dda2-4cad-9c19-101fe8260286

Public Version Date

March 27, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-