Catalog Number

-

Brand Name

TROJAN 100CT BULK MIX

Version/Model Number

00022600019831

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

-

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

K120287,K901192,K901194,K912901,K120287,K901192,K901194,K912901

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

7a320b53-ddd1-4057-aea6-f74105bc115d

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-