Duns Number:070637129
Device Description: THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, FLAMMABLEThe u THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, FLAMMABLEThe use of Uro-Bond® Thinner may be deemed necessary where Uro-Bond® III Brush-on Silicone Adhesives have thickened (this sometimes occurs when the bottles are opened frequently as the solvents used are highly evaporative in nature). Suggested uses include but are not limited to use as a dilutant for Uro-Bond® III Brush-on Silicone Adhesive as well as a degreasing agent or a solvent. However, Urocare® does not recommend the use of Uro-Bond® Thinner as an adhesive remover—we recommend using an alternative product for that purpose—see Urocare® Adhesive Remover Pads #5600.NOTE: Since the actual use of Uro-Bond® Thinner or products otherwise incorporating Uro-Bond® Thinner 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.FLAMMABLE
Catalog Number
501003
Brand Name
Uro-Bond® Thinner for Uro-Bond III Adhesive 3 oz. (88.7 mL.)
Version/Model Number
501003
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
751d06ef-80eb-4395-9a9c-6b96c842d308
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 01, 2018
Package DI Number
10792293501032
Quantity per Package
12
Contains DI Package
00792293501035
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 |