Catalog Number

-

Brand Name

Spice Up Your Sex Life

Version/Model Number

SU8793

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

K002571,K002571,K002571

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

e0b743c7-408b-4e5d-9cab-3210c7383bee

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Package DI Number

20860000864804

Quantity per Package

24

Contains DI Package

10860000864807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case