Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.) 5000015

GUDID 00792293500151

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.

UROCARE PRODUCTS, INC.

Urinary incontinence penis sheath/port, single-use, non-sterile

Primary Device ID	00792293500151
NIH Device Record Key	132959a3-dd0f-4a8e-b187-6b51dc737799
Commercial Distribution Status	In Commercial Distribution
Brand Name	Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.)
Version Model Number	5000015
Catalog Number	5000015
Company DUNS	070637129
Company Name	UROCARE PRODUCTS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM

Device Dimensions

Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch
Weight	0.26 Pound
Total Volume	1.5 Fluid Ounce
Total Volume	44.4 Milliliter
Height	2.88 Inch
Length	1.6 Inch
Width	1.6 Inch

Operating and Storage Conditions

Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment Temperature	Between 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment Temperature	Between 4.5 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293500151 [Primary]
GS1	10792293500158 [Package] Package: Case [12 Units] In Commercial Distribution

FDA Product Code

KGX	Tape And Bandage, Adhesive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-07-06
Device Publish Date	2018-06-01

Devices Manufactured by UROCARE PRODUCTS, INC.

00792293781802 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags hav
00792293781819 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags ha
00792293783202 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags ha
00792293783219 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags h
00792293791801 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags hav
00792293791818 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags ha
00792293793201 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags ha
00792293793218 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)	2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags h