Uro-Cath® Molded-Latex Male External Catheter, 30mm with Urofoam®-2 & Uro-Prep® - These male external catheters are commonly - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: These male external catheters are commonly referred to as a “Molded-Latex” style because t These male external catheters are commonly referred to as a “Molded-Latex” style because they are dipped from a single piece of latex without seams rather than assembled from multiple components. Each Uro-Cath® catheter has a thin, latex sheath section similar to a condom at one end—the part that is rolled over the head and shaft of the penis—and a heavier funnel-shaped, cup section at the other—where urine is drained from into a bag or other collection device—making them virtually “twist-proof” by their unique design. Uro-Cath® catheters range in size from 25mm, our smallest, to 40mm, our largest in 5mm increments to suit a variety of individual requirements. They are packaged individually in a window pouch allowing for quick, easy product identification without opening the pouch. The back side of the pouch contains detailed, illustrated, application instructions relative to the product purchasedContains:1 Uro-Cath® Male External Catheter,1 Urofoam®-2 Double-Sided Adhesive Foam Strip,1 Uro-Prep® Protective Skin Barrier Wipe,Illustrated, application instructions on back of pouch/package

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More Product Details

Catalog Number

5221530

Brand Name

Uro-Cath® Molded-Latex Male External Catheter, 30mm with Urofoam®-2 & Uro-Prep®

Version/Model Number

5221530

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

-

Product Code Details

Product Code

NNX

Product Code Name

Device, Incontinence, Urosheath Type, Non-Sterile

Device Record Status

Public Device Record Key

a62a0f5f-4ed5-44d5-9c16-543d5fb9026c

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 30, 2018

Additional Identifiers

Package DI Number

10792293221534

Quantity per Package

50

Contains DI Package

00792293221537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"UROCARE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 140
2 A medical device with a moderate to high risk that requires special controls. 6