Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.)

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) FDA UDI
Generic Name: Urinary incontinence penis sheath/port, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 500003 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 500003 FDA UDI
Primary DI / UDI-DI: 00792293500038 FDA UDI
FDA Product Code: NNX FDA UDI
KGX FDA UDI
EZR 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
880.5240 FDA UDI
876.5900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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Over-the-Counter

Yes

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Width — 2.0 Inch FDA UDI
Length — 2.0 Inch FDA UDI
Height — 3.56 Inch FDA UDI
Total Volume — 88.7 Milliliter FDA UDI
Total Volume — 3 Fluid Ounce FDA UDI
Weight — 0.52 Pound FDA UDI

Category: Urinary incontinence penis sheath/port, single-use Skin surface device adhesive

Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI f1b4c413-6c1f-4e7b-945d-1e45708bc241 37 fields · synced Jun 1, 2026