Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) - ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABL 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.

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More Product Details

Catalog Number

500003

Brand Name

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

Version/Model Number

500003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EZR

Product Code Name

Cement, Stomal Appliance, Ostomy

Device Record Status

Public Device Record Key

f1b4c413-6c1f-4e7b-945d-1e45708bc241

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 01, 2018

Additional Identifiers

Package DI Number

10792293500035

Quantity per Package

12

Contains DI Package

00792293500038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"UROCARE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 140
2 A medical device with a moderate to high risk that requires special controls. 6