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Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm 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 “Self-Adhering” style because they are contain an adhesive on the inside of the sheath which adheres to the skin when the catheter sheath is unrolled. Each Uro-Cath® II catheter has a thin, silicon 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. A retainer tray is provided to keep the catheters round shape while in storage. Uro-Cath® II catheters come in 24mm, 28mm, 31mm, 35mm and 40mm sizes 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–no “cookie-cutter” or “one fits all” instructions for all products like some similar products have. Once removed from the packaging and the retainer tray is removed, each catheter may be secured by simply unrolling the sheath over the shaft of the penis and firmly grasping around the shaft to ensure a secure fit for maximum comfort and security. Contains: 1 Uro-Cath® II Male External Catheter, Illustrated, application instructions on back of pouch/package. FDA UDI
Model / Reference
530128 FDA UDI
Description
These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on the inside of the sheath which adheres to the skin when the catheter sheath is unrolled. Each Uro-Cath® II catheter has a thin, silicon 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. A retainer tray is provided to keep the catheters round shape while in storage. Uro-Cath® II catheters come in 24mm, 28mm, 31mm, 35mm and 40mm sizes 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–no “cookie-cutter” or “one fits all” instructions for all products like some similar products have. Once removed from the packaging and the retainer tray is removed, each catheter may be secured by simply unrolling the sheath over the shaft of the penis and firmly grasping around the shaft to ensure a secure fit for maximum comfort and security. Contains: 1 Uro-Cath® II Male External Catheter, Illustrated, application instructions on back of pouch/package. FDA UDI

Identifiers

Catalog Number
530128 FDA UDI
Primary DI / UDI-DI
00792293301284 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

No

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
Outer Diameter — 28 Millimeter FDA UDI
Weight — 0.015 Pound FDA UDI

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

Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm 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

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Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI 9776a1da-9886-41dd-9360-a0bdbcb2591e 37 fields · synced May 30, 2026