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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Uro-Bond® V Brush-On Non-Flammable Silicone Adhesive 1.5 oz. (44.4 mL.) - 00792293505156

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Non-Hazmat & Non-Flammable—no special handling required. • Low Odor—Virtually odor free. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! 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.
UROCARE PRODUCTS, INC.
5005015
In Commercial Distribution

  • 10792293505153 ()
  • 00792293505156 ()

  • Width: 2.0 Inch
  • Length: 2.0 Inch
  • Height: 3.56 Inch
  • Total Volume: 88.7 Milliliter
  • Total Volume: 3 Fluid Ounce
  • Weight: 0.26 Pound
5005015

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

Uro-Bond® V Brush-On Non-Flammable Silicone Adhesive 3 oz. (88.7 mL.) - 00792293505033

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Non-Hazmat & Non-Flammable—no special handling required. • Low Odor—Virtually odor free. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! 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.
UROCARE PRODUCTS, INC.
500503
In Commercial Distribution

  • 00792293505033 ()
  • 10792293505030 ()

  • Weight: 0.55 Pound
  • Total Volume: 3 Fluid Ounce
  • Total Volume: 88.7 Milliliter
  • Height: 4.38 Inch
  • Length: 2.38 Inch
  • Width: 2.38 Inch
500503

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

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

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.
UROCARE PRODUCTS, INC.
501503
In Commercial Distribution

  • 00792293501530 ()
  • 10792293501537 ()

  • 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
501503

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

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

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
UROCARE PRODUCTS, INC.
501003
In Commercial Distribution

  • 00792293501035 ()
  • 10792293501032 ()

  • 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
501003

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

Uro-Bond® III Brush-On Silicone Adhesive 1.53 oz. (44.4 mL.) - 00792293500151

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! 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.
UROCARE PRODUCTS, INC.
5000015
In Commercial Distribution

  • 00792293500151 ()
  • 10792293500158 ()

  • Weight: 0.26 Pound
  • Total Volume: 1.5 Fluid Ounce
  • Total Volume: 44.4 Milliliter
  • Height: 2.88 Inch
  • Length: 1.6 Inch
  • Width: 1.6 Inch
5000015

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) - 00792293500038

ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! 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.
UROCARE PRODUCTS, INC.
500003
In Commercial Distribution

  • 10792293500035 ()
  • 00792293500038 ()

  • Width: 2.0 Inch
  • Length: 2.0 Inch
  • Height: 3.56 Inch
  • Total Volume: 88.7 Milliliter
  • Total Volume: 3 Fluid Ounce
  • Weight: 0.52 Pound
500003

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive

Urocare® Male Urinal to Latex Leg Bag Adapter - 00792293060228

ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENT Replacement Male Urinal Adapter for all Urocare Male Urinal Systems: #94404, #94403, #94402, #94401, #94400, #94399 and Urinal Kits: #4404, #4403, #4402, #4401, #4400 and #4399. Includes Gasket-Ring #5999 preassembled.
UROCARE PRODUCTS, INC.
6022
In Commercial Distribution

  • 00792293060228 ()
  • 10792293060225 ()

  • Outer Diameter: 0.84 Inch
  • Height: 1.24 Inch
  • Weight: 0.013 Pound
6022

  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal

Urocare® Adhesive Remover Pads (Box of 50) - 00792293056009

ADHESIVE REMOVER, PADS, WIPES, SACHETTE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Urocare® adhesive remover has been specifically formulated for dissolving and removing unwanted adhesive or adhesive residue from urinary and ostomy appliances, tens units, monitoring electrodes, skin and can even be used for the removal of tar. Packaged in a small, convenient wipe, Urocare® adhesive remover pads are the perfect solution to aid in the removal of adhesive residue left behind by male external catheters. They may be used to soften the adhesive of double-sided adhesive foam strips as well as most brush-on medical adhesives. They contain a lab tested, non-toxic, citrus-based solution that may also be used to remove these types of medical adhesives or adhesive residue from skin and appliances in preparation for the use of a new adhesive strip/wafer. It is recommended that a male external catheter be changed once a day to promote healthy skin. With the use of Urocare® adhesive remover pads, a male external catheter can be changed quickly and easily. Key Features: • NON-TOXIC—Lab Tested, non-toxic and free from harsh solvents. • Citrus-Based—Fresh citrus scent and biodegradable. • Many Uses—Use on nitro patches, tens units, electrodes, even tar. • Convenient—Travel size pads are small and easy to use • Soap & Water Clean-Up—Just wash, rinse and dry • Suitable for Hospital, Long-Term Care and Home Use • Alcohol-Free Formula • Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons • Convenient Packaging—Use only what you need so there's less waste Note: For external use only.
UROCARE PRODUCTS, INC.
5600
In Commercial Distribution

  • 00792293056009 ()

  • Width: 2.25 Inch
  • Depth: 0.1 Inch
  • Height: 2.25 Inch
  • Weight: 0.004 Pound
5600

  • Patient medical adhesive remover
  • Skin surface device adhesive
  • Urinary incontinence penis sheath/port, single-use

Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25" OD (Box of 30) - 00792293053008

DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for the unique bonding applications of appliances to the skin and are suitable for securing valve housings of voice restoration systems to the body. With adhesive coated on both sides, they provide a comfortable, air-tight seal that conforms to the irregular contours of the stoma and eliminate hissing a side effect often found in other thinner or less flexible products. Key Features: • Ensolite Foam—Hypo-Allergenic • Closed-Cell Foam Structure—for an air-tight seal that eliminates hissing. • Soft and Pliable—Easily conforms to irregular contours of the body. • Perspiration resistant—It retains it's adhesive qualities even when sweating. • Easy to apply and Remove—Just peel 'n' Stick to apply, peel back to remove. If the disc is difficult to remove, Urocare® Adhesive Remover Pads may be used to soften the adhesive and assist in the removal of the disc. They contain a non-toxic, citrus-based adhesive remover that may also be used to remove most types of medical adhesive or adhesive residue from skin and appliances or in preparation for use of a new disc. Most medical grade adhesive removers will work basically in the same manner; however, consult your doctor or speech therapist to decide the best product for you and how to use it safely. For more information—see Urocare® Adhesive Remover Pads (#5600). In the event of skin that has become sensitive to aggressive medical adhesives, Urocare® has developed Uro-Prep® a protective skin barrier wipe for used under all types of medical adhesives. They protect delicate, sensitive skin from aggressive adhesives often used in conjunction with urinary or ostomy appliances. Uro-Prep® wipes are safe, effective, and for external use only. For more information—see Uro-Prep® (#5500).
UROCARE PRODUCTS, INC.
5300
In Commercial Distribution

  • 00792293053008 ()

  • Outer Diameter: 2.25 Inch
  • Lumen/Inner Diameter: 1.0 Inch
  • Height: 0.13 Inch
  • Standard
  • Weight: 0.002 Pound
5300

  • Tracheostomy tube dressing
  • Tracheostomy tube speech valve
  • Intestinal ostomy base plate, concave
  • Skin surface device adhesive

Urocare® Male Urinal Suspensory Garment, Laced Closure, XLarge 46" to 54" Waist - 00792293044235

URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 46" TO 54" (117CM TO 137CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94404 & #4404.
UROCARE PRODUCTS, INC.
4423
In Commercial Distribution

  • 00792293044235 ()

  • 117cm to 137cm Waist
  • 46" to 54" Wasit
  • Weight: 0.20 Pound
4423

  • Penis/scrotum wearable urinal
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