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Found 8 results
510(k) Data Aggregation
K Number
K143017Device Name
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
Manufacturer
LABORATOIRES URGO
Date Cleared
2015-08-07
(291 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.
Device Description
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface.
In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain.
It is supplied sterile in an individual pouch.
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K Number
K123219Device Name
URGOCLEAN ABSORBENT WOUND DRESSING
Manufacturer
LABORATOIRES URGO
Date Cleared
2013-03-18
(154 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.
Device Description
Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad coated with a soft-adherent lipido-colloid layer on the dressing/wound interface. In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, allowing a one piece and painless removal. It is supplied sterile in an individual pouch.
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K Number
K100429Device Name
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
Manufacturer
LABORATOIRES URGO
Date Cleared
2010-06-11
(115 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.
Device Description
Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:
- in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)
- a non-sensitising, super-absorbent polyurethane foam pad,
- a protective, semi-permeable polyurethane backing.
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K Number
K100430Device Name
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
Manufacturer
LABORATOIRES URGO
Date Cleared
2010-06-11
(115 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
Device Description
Urgotul® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver (2.25 mq/sq.inch).
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K Number
K062559Device Name
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
Manufacturer
LABORATOIRES URGO
Date Cleared
2007-01-29
(152 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.
Device Description
Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.
Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgocell® Ag is composed of three layers :
- in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
- a non-sensitising, super-absorbent polyurethane foam pad, -
- a protective, semi-permeable polyurethane backing. -
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K Number
K061220Device Name
URGOTUL AG
Manufacturer
LABORATOIRES URGO
Date Cleared
2006-07-27
(87 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
Device Description
Urgotul® Ag wound dressing is a sterile, antimicrobial hydrocolloid wound contact dressing with silver. Urgotul® Ag wound dressing is non-occlusive and non-adhesive for painless removal. Urgotul® Ag is composed of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver.
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K Number
K974348Device Name
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
Manufacturer
LABORATOIRES URGO S.A.
Date Cleared
1998-02-13
(86 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.
Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.
Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
Device Description
ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.
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K Number
K970518Device Name
ALGOPLAQUE HYDROCOLLOID DRESSING
Manufacturer
LABORATOIRES URGO S.A.
Date Cleared
1997-03-21
(38 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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