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Uro-Cath® Molded-Latex Male External Catheter, Large 35mm

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Cath® Molded-Latex Male External Catheter, Large 35mm 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 “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 purchased Contains: 1 Uro-Cath® Male External Catheter, Illustrated, application instructions on back of pouch/package FDA UDI
Model / Reference
520135 FDA UDI
Description
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 purchased Contains: 1 Uro-Cath® Male External Catheter, Illustrated, application instructions on back of pouch/package FDA UDI

Identifiers

Catalog Number
520135 FDA UDI
Primary DI / UDI-DI
00792293201355 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
Weight — 0.014 Pound FDA UDI
Outer Diameter — 35 Millimeter FDA UDI

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

Uro-Cath® Molded-Latex Male External Catheter, Large 35mm by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 ab245ea6-3a1f-4194-95d8-a56993fc52b8 36 fields · synced May 31, 2026