DEVICE: Uro-Bond® Thinner for Uro-Bond V Non-Flammable Adhesive 3 oz. (88.7 mL.) (00792293501530)

Device Identifier (DI) Information

Uro-Bond® Thinner for Uro-Bond V Non-Flammable Adhesive 3 oz. (88.7 mL.)
501503
In Commercial Distribution
501503
UROCARE PRODUCTS, INC.
00792293501530
GS1

1
070637129 *Terms of Use
THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, NON-FLAMMABLE The use of Uro-Bond® Thinner may be deemed necessary where Uro-Bond® V 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® V 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® 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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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
NNX Device, Incontinence, Urosheath Type, Non-Sterile
KGX Tape And Bandage, Adhesive
EZR Cement, Stomal Appliance, Ostomy
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 4.5 and 22 Degrees Celsius
Handling Environment Temperature: between 40 and 72 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Width: 2.38 Inch
Length: 2.38 Inch
Height: 4.38 Inch
Total Volume: 88.7 Milliliter
Total Volume: 3 Fluid Ounce
Weight: 0.55 Pound
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Device Record Status

bc166c00-06ba-40dd-94de-bfcae403e6fc
November 09, 2022
4
May 31, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10792293501537 12 00792293501530 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
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