CautionWear Grande - Male Latex Condom, Parallel-Sided, Smooth - CAUTION WEAR CORP

Duns Number:177056145

Device Description: Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon- Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.

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More Product Details

Catalog Number

-

Brand Name

CautionWear Grande

Version/Model Number

CW0001GR

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012964,K012964,K012964,K012964,K012964,K012964,K012964,K012964

Product Code Details

Product Code

HIS

Product Code Name

Condom

Device Record Status

Public Device Record Key

979f4710-f25d-4a25-a90a-03850e9e4b7c

Public Version Date

July 15, 2021

Public Version Number

6

DI Record Publish Date

October 11, 2017

Additional Identifiers

Package DI Number

00850836007502

Quantity per Package

4000

Contains DI Package

00850836007472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAUTION WEAR CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1