Uro-Bond® Thinner for Uro-Bond III Adhesive 3 oz. (88.7 mL.)

Basic Information

• Brand Name: Uro-Bond® Thinner for Uro-Bond III Adhesive 3 oz. (88.7 mL.)
• Primary DI: 00792293501035
• Version / Model: 501003
• Catalog Number: 501003
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 751d06ef-80eb-4395-9a9c-6b96c842d308

Device Description

THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, FLAMMABLE The 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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	876.5250	1
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34929	Urinary incontinence penis sheath/port, single-use	A 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.	No	Active
10035	Skin surface device adhesive	A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293501035	GS1
Package	10792293501032	GS1	Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	0.44	Pound
Total Volume	3	Fluid Ounce
Total Volume	88.7	Milliliter
Height	3.56	Inch
Length	2.0	Inch
Width	2.0	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 40 – 72 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 4.5 – 22 Degrees Celsius