AccessGUDID - DEVICE: Uro-Bond® Thinner for Uro-Bond III Adhesive 3 oz. (88.7 mL.) (00792293501035)

GUDID

Device Identifier (DI) Information

Brand Name: Uro-Bond® Thinner for Uro-Bond III Adhesive 3 oz. (88.7 mL.)
Version or Model: 501003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501003
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293501035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive
NNX	Device, Incontinence, Urosheath Type, Non-Sterile
EZR	Cement, Stomal Appliance, Ostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 40 and 72 Degrees Fahrenheit
Handling Environment Temperature: between 4.5 and 22 Degrees Celsius

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 751d06ef-80eb-4395-9a9c-6b96c842d308
Public Version Date: November 09, 2022
Public Version Number: 4
DI Record Publish Date: June 01, 2018