← Back to catalogue

Uro-Con® Texas-Style Male External Catheter, Medium 30mm 4" Tube with Urofoam®-2

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Con® Texas-Style Male External Catheter, Medium 30mm 4" Tube with Urofoam®-2 FDA UDI
Generic Name
Urinary incontinence penis sheath/port, single-use FDA UDI
Device Name
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 purchased Contains: 1 Uro-Con® Male External Catheter, 1 Urofoam®-2 Double-Sided Adhesive Foam Strip, Illustrated, application instructions on back of pouch/package FDA UDI
Model / Reference
512430 FDA UDI
Description
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 purchased Contains: 1 Uro-Con® Male External Catheter, 1 Urofoam®-2 Double-Sided Adhesive Foam Strip, Illustrated, application instructions on back of pouch/package FDA UDI

Identifiers

Catalog Number
512430 FDA UDI
Primary DI / UDI-DI
00792293124302 FDA UDI
FDA Product Code
NNX FDA UDI
GMDN Term
Urinary incontinence penis sheath/port, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 4 Inch FDA UDI
Outer Diameter — 30 Millimeter FDA UDI
Weight — 0.023 Pound FDA UDI

Category: Urinary incontinence penis sheath/port, single-use

Uro-Con® Texas-Style Male External Catheter, Medium 30mm 4" Tube with Urofoam®-2 by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Urinary incontinence penis sheath/port, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI cd63834a-2b99-464d-988f-998349858d2c 36 fields · synced Jun 8, 2026