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

Primary DI
00792293500151
Brand
Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.)
Company
UROCARE PRODUCTS, INC.
Model
5000015
Catalog number
5000015
Device description
ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLEUro-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.
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZRCement, Stomal Appliance, Ostomy
KGXTape And Bandage, Adhesive
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1
KGXTape And Bandage, AdhesiveGeneral Hospital1
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10792293500158PackageGS112In Commercial Distribution
00792293500151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079229350015810792293500158
00792293500151007922935001517922935001510792293500151

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.88Inch
Length1.6Inch
Total Volume1.5Fluid Ounce
Total Volume44.4Milliliter
Weight0.26Pound
Width1.6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4.5 Degrees Celsius22 Degrees Celsius
Handling Environment Temperature40 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
070637129
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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