Uro-Con® Texas-Style Male External Catheter, Small 25mm 4" Tube with Urofoam®-1 - These male external catheters are commonly - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: These male external catheters are commonly referred to as a “Texas-Style” because they emp These male external catheters are commonly referred to as a “Texas-Style” because they employ a three-piece construction technique. Each Uro-Con® catheter has a thin, latex sheath similar to a condom—which is rolled over the head and shaft of the penis—and is attached to a 4"(10cm) or 2"(5cm) white-rubber tube—where urine is drained from into a bag or other collection device—by an plastic catheter insert. Using a “Condom” type sheath makes these catheters “fully collapsible” to prevent pooled urine a major cause of skin irritation and break-down. Uro-Con® catheters range in size from 25mm, our smallest, to 35mm, 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-Con® Male External Catheter,1 Urofoam®-1 Single-Sided Adhesive Foam Strip,Illustrated, application instructions on back of pouch/package

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More Product Details

Catalog Number

511425

Brand Name

Uro-Con® Texas-Style Male External Catheter, Small 25mm 4" Tube with Urofoam®-1

Version/Model Number

511425

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

cac42c04-9849-4007-83ba-744c33fe6168

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 30, 2018

Additional Identifiers

Package DI Number

10792293114256

Quantity per Package

50

Contains DI Package

00792293114259

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