Uro-Bond® III Brush-On Silicone Adhesive 3 Oz. (88.7 Ml.)

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically…

Registry build 21.09.26

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based → for best bio-compatibility. • Completely Transparent → Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces → including other silicones. • Water and perspiration resistant → It retains it’s adhesive qualities even under water. • Brush adhesive just where you need it → No messy sprays which get adhesive everywhere! NOTE: Since the actual use of Uro-Bond® or products otherwise incorporating Uro-Bond® by others is beyond the control of Urocare®, it is the user’s responsibility to independently determine the safety, toxicity, suitability and acceptability of the product’s performance in a specific application for his/her own use.

13manufacturers in China registered for this device type
1catalogue number

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.

Chinese manufacturers registered for FDA product code NNX
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

Regulatory record for Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.)
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 2018-06-01
Record revised 2022-11-09 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Handling environment temperature 4.5 to 22 °C; Handling environment temperature 40 to 72 °F
Packaging Case of 12
Sizes Width 2 in; length 2 in; height 3.56 in; total volume 88.7 ml; total volume 3 Fluid Ounce; weight 0.52 lb

Catalogue Numbers

Catalogue numbers for Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.)
Catalogue number Size Status
500003 Width 2.0 in In distribution

Same Product Code

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer