Trojan™ Ultra Thin Bulk - CHURCH & DWIGHT CO., INC.

Duns Number:001211952

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More Product Details

Catalog Number

-

Brand Name

Trojan™ Ultra Thin Bulk

Version/Model Number

00022600000310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HIS

Product Code Name

CONDOM

Device Record Status

Public Device Record Key

043136d1-f754-4772-91c8-932013c25470

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHURCH & DWIGHT CO., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80
U Unclassified 2