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Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.)

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 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
5000015 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
5000015 FDA UDI
Primary DI / UDI-DI
00792293500151 FDA UDI
FDA Product Code
KGX FDA UDI
NNX 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
880.5240 FDA UDI
876.5250 FDA UDI
876.5900 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
Weight — 0.26 Pound FDA UDI
Total Volume — 1.5 Fluid Ounce FDA UDI
Total Volume — 44.4 Milliliter FDA UDI
Height — 2.88 Inch FDA UDI
Length — 1.6 Inch FDA UDI
Width — 1.6 Inch FDA UDI

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

Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin surface device adhesive.

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 132959a3-dd0f-4a8e-b187-6b51dc737799 37 fields · synced May 30, 2026