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.
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
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
EZR
Product Code Name
Cement, Stomal Appliance, Ostomy
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
Package DI Number
10792293500035
Quantity per Package
12
Contains DI Package
00792293500038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |