URGO Medical North America, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010060216	3010060216	URGO Medical North America, LLC	1	Y	2026-01-01	100 Lexington Street, Suite 400 Fort Worth TX US 76102

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00851383003122	Vashe Wound Solution 118 ml container - Flip Cap - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 118 ml (4 fl. oz.) size with a flip top cap.	855-888-8273	info@us.urgo.com
00851383003139	Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz) size with a flip top cap.	855-888-8273	info@us.urgo.com
00851383003146	Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debridmement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) container size with a flip top cap.	855-888-8273	info@us.urgo.com
00851383003160	Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz)) size with an instillation cap.	855-888-8273	info@us.urgo.com
00851383003177	Vashe Wound Solution 475 ml (16 fl oz) Instillation Container - Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) size with an instillation cap.	855-888-8273	info@us.urgo.com
00851383003221	Vashe Wound Solution 1 L (34 fl oz) Flip Top Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the flip top cap.	855-888-8273	info@us.urgo.com
00851383003238	Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap.	855-888-8273	info@us.urgo.com
00851383003634	Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap - Vashe® Antimicrobial Wound Gel is an aqueous gel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and formsa protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. Amoist wound environment is also supportive of the healing process by aiding autolytic debridement.The hypochlorous acid in Vashe Antimicrobial Wound Gel acts as a preservative to kill and inhibit growth of microorganisms in the bottle and on gauze or cover dressings.	855-888-8273	info@us.urgo.com

us.urgo.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
151200	1195047778	K141863	PURICORE WOUND HYDROGEL SPRAY DRESSING	FRO	2015-05-14
151200	1094105124	K131848	VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)	FRO	2014-03-31
151200	1604509233	K093697	VASHE WOUND THERAPY SOLUTION	FRO	2010-04-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FRO	3	2015-05-14

GUDID#

Vashe Wound Solution 118 ml container - Flip Cap - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 118 ml (4 fl. oz.) size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
2019-12-02
Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debridmement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) container size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-02-03
Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz)) size with an instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-02-07
Vashe Wound Solution 475 ml (16 fl oz) Instillation Container - Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) size with an instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-04-01
Vashe Wound Solution 1 L (34 fl oz) Flip Top Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-04-01
Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-04-01
Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap - Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz) size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
2020-02-03
Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap - Vashe® Antimicrobial Wound Gel is an aqueous gel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and formsa protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. Amoist wound environment is also supportive of the healing process by aiding autolytic debridement.The hypochlorous acid in Vashe Antimicrobial Wound Gel acts as a preservative to kill and inhibit growth of microorganisms in the bottle and on gauze or cover dressings.
URGO MEDICAL NORTH AMERICA, LLC
2025-11-17
Vashe Sterile Sleeve - The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip.
URGO MEDICAL NORTH AMERICA, LLC
2017-07-17
Vashe Wipes Skin Cleansing Solution Kit - The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and dry, nonwoven wipes. The user is instructed to wet the wipes with the Solution just prior to use. The Kit is intended for use in cleansing patient skin.
URGO MEDICAL NORTH AMERICA, LLC
2018-03-28
Vashe Wound Solution OTC - Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
2021-12-07
URGOK2 - UrgoK2 is a two Layer Compression System -KTECH; a short - stretch bandage, providing compression, protection and absorbency and KPRESS; a cohesive long-stretch bandage providing the compression necessary to achieve therapeutic pressure and secures the bandages in place.UrgoK2 is for the treatment of venous leg ulcers, venous edema and lymphedema requiring full compression.Not made with natural rubber latex.
URGO MEDICAL NORTH AMERICA, LLC
2019-12-26
URGOK2 Lite - URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place.URGOK2 Lite is for the treatment of venous or mixed leg ulcers, venous edema and lymphedema, which require a reduced level of compression.Not made with natural rubber latex.
URGO MEDICAL NORTH AMERICA, LLC
2019-12-20
URGOK2 - URGOK2 is a two layer compression system including KTECH: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place.URGOK2 is for the treatment of venous leg ulcer, venous edema and lymphedema, which require full compression.Not made with natural rubber latex.
URGO MEDICAL NORTH AMERICA, LLC
2019-12-20
URGOK2 Lite - URGOK2 Lite is a two layer Compression System which includes KTECH Lite: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place.URGOK2 Lite is for the treatment of venous or mixed leg ulcers, venous edema and lymphedema, which require reduced level of compression.Not made with natural rubber latex.
URGO MEDICAL NORTH AMERICA, LLC
2019-12-20
Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap - Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2020-02-03
Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 - Drawtex Hydroconductive Wound Dressing with LevaFiber 18X0.39 (1 bx of 10 strips) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-12-02
Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 - Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 - Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 4X4 - Drawtex Hydroconductive Wound Dressing with LevaFiber 4X4 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 6X8 - Drawtex Hydroconductive Wound Dressing with LevaFiber 6X8 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8 - Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 3X39 - Drawtex Hydroconductive Wound Dressing with LevaFiber 3X39 (1 bx of 5 rolls) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 4 X 39 - Drawtex Hydroconductive Wound Dressing with LevaFiber 4X39 (1 bx of 5 rolls) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber 39X8 - Drawtex Hydroconductive Wound Dressing with LevaFiber 39X8 (1 bx of 5 rolls) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Drawtex Hydroconductive Wound Dressing with LevaFiber TRACH 4X4 - Drawtex Hydroconductive Wound Dressing with LevaFiber TRACH (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
URGO MEDICAL NORTH AMERICA, LLC
2019-11-01
Resta Silver Gel Bellows Bottle - Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
URGO MEDICAL NORTH AMERICA, LLC
2021-12-07
Vashe Wound Solution OTC - Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
2021-12-07
Resta Silver Gel Bellows Bottle - Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
URGO MEDICAL NORTH AMERICA, LLC
2021-12-07
Resta Silver Gel Tube - Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
URGO MEDICAL NORTH AMERICA, LLC
2021-12-07
UrgoTul - A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed in a petroleum jelly matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul - A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed in a petroleum jelly matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul - A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particle dispersed in a petroleum jelly matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb - A soft-adherent lipido-colloid foam dressing consisting of a polyurethane pad with a micro-adherent lipido-colloid matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb - A soft-adherent lipido-colloid foam dressing consisting of coating a polyurethane pad with a micro-adherent lipido-colloid matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb - A soft-adherent lipido-colloid foam dressing consisting of coating on a polyurethane pad with a micro-adherent lipido colloid matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb - A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb Border - A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb Border - A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01
UrgoTul Absorb Border - A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.
URGO MEDICAL NORTH AMERICA, LLC
2019-03-01

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