DEVICE: Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.) (00792293500151)

Device Identifier (DI) Information

Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.)
5000015
In Commercial Distribution
5000015
UROCARE PRODUCTS, INC.
00792293500151
GS1

1
070637129 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34929 Urinary incontinence penis sheath/port, single-use
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
Active false
10035 Skin surface device adhesive
A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGX Tape And Bandage, Adhesive
NNX Device, Incontinence, Urosheath Type, Non-Sterile
EZR Cement, Stomal Appliance, Ostomy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 40 and 72 Degrees Fahrenheit
Handling Environment Temperature: between 4.5 and 22 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
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
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Device Record Status

132959a3-dd0f-4a8e-b187-6b51dc737799
November 09, 2022
4
June 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10792293500158 12 00792293500151 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
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