FDA.report

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

Primary DI
00792293501530
Brand
Uro-Bond® Thinner for Uro-Bond V Non-Flammable Adhesive 3 oz. (88.7 mL.)
Company
UROCARE PRODUCTS, INC.
Model
501503
Catalog number
501503
Device description
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.
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10792293501537PackageGS112In Commercial Distribution
00792293501530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1079229350153710792293501537
00792293501530007922935015307922935015300792293501530

GMDN Terms

TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile 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.

Device Sizes

TypeValueUnit
Height4.38Inch
Length2.38Inch
Total Volume3Fluid Ounce
Total Volume88.7Milliliter
Weight0.55Pound
Width2.38Inch

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature4.5 Degrees Celsius22 Degrees Celsius
Handling Environment Temperature40 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags

DUNS number
070637129
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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