Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) 500003

GUDID 10792293500035

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 Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use
Primary Device ID10792293500035
NIH Device Record Keyf1b4c413-6c1f-4e7b-945d-1e45708bc241
Commercial Distribution StatusIn Commercial Distribution
Brand NameUro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.)
Version Model Number500003
Catalog Number500003
Company DUNS070637129
Company NameUROCARE PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM

Device Dimensions

Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound
Width2 Inch
Length2 Inch
Height3.56 Inch
Total Volume88.7 Milliliter
Total Volume3 Fluid Ounce
Weight0.52 Pound

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit
Handling Environment TemperatureBetween 4.5 Degrees Celsius and 22 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 72 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100792293500038 [Primary]
GS110792293500035 [Package]
Contains: 00792293500038
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-01

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