Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm
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…
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.
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
Showing 12 of 13. All 13 manufacturers in China registered for Device, Incontinence, Urosheath Type, Non-Sterile
Record
| Listed by | Urocare Products, Inc., United States |
|---|---|
| FDA product code | NNX |
| Device type | Device, Incontinence, Urosheath Type, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place away from direct sunlight |
| Sizes | Outer diameter 24 to 40 mm; weight 0.015 lb |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 530124 | Outer Diameter 24 mm | In distribution |
| 530128 | Outer Diameter 28 mm | In distribution |
| 530140 | Outer Diameter 40 mm | In distribution |
| 530131 | Outer Diameter 31 mm | In distribution |
| 530135 | Outer Diameter 35 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clear Advantage Male Continence Sheath | C.R. Bard, Inc. | 40 |
| Spirit® Hydrocolloid Adhesive Sheath | C.R. Bard, Inc. | 30 |
| Aurora Hydrocolloide Adhesive Sheath | C.R. Bard, Inc. | 15 |
| Transfix Continence Sheath | C.R. Bard, Inc. | 15 |
| Freedom Clear | Coloplast A/S | 14 |
| UltraFlex™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Freedom Clear Advantage | Coloplast A/S | 10 |
| InView Extra | Hollister Incorporated | 10 |
| Wideband™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Clear Advantage Spirit Adhesive Sheath | C.R. Bard, Inc. | 10 |
| Pop-On™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| InView Standard | Hollister Incorporated | 10 |
Showing 12 of 86. All products under Device, Incontinence, Urosheath Type, Non-Sterile
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.