Catalog Number

-

Brand Name

Trustex Chocolate

Version/Model Number

L4020

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

761ecfdf-aa02-4757-9559-cebdff7f83b6

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Package DI Number

10726893112411

Quantity per Package

12

Contains DI Package

00726893112414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bundle of 12, 3 pks