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510(k) Data Aggregation
K Number
K012995Device Name
COLLATEK SHEET
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-10-25
(49 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek Sheet may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage 1-1V) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Device Description
Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
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K Number
K012997Device Name
COLLATEK FOAM
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-10-25
(49 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek Foam may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage I-IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Device Description
Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.
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K Number
K001508Device Name
LASERSKIN DRESSING
Manufacturer
FIDIA ADVANCED BIOPOLYMERS SRL
Date Cleared
2001-07-25
(436 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990079Device Name
FASTSEAL CHEST WOUND DRESSING
Manufacturer
GREENFIELD MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-12-23
(346 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds.
- 2. To be used on a temporary and emergency basis in the management of an open pneumothorax condition.
- 3. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.
Device Description
Not Found
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K Number
K991214Device Name
SIMPLICARE TRANSPARENT WOUND DRESSING
Manufacturer
HOLLISTER, INC.
Date Cleared
1999-10-14
(188 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings.
The SimpliCare Transparent Wound Dressing is indicated for use on wounds including:
- minor burns and scalds .
- superficial cuts, lacerations and abrasions ●
- minor irritations of the skin .
This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as:
- pressure ulcers .
- lacerations/abrasions .
- surgical incisions .
- . second degree burns
- donor sites .
In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device
Device Description
The Hollister SimpliCare Transparent Wound Dressing is a polyurethane film that is backed with a pressure sensitive acrylic adhesive. A unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Transparent Wound Dressing is designed to have a high moisture vapor transmission rate and is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Transparent Wound Dressing provides a barrier to viral and bacterial contaminates and other external contaminants such as feces and urine while the dressing remains intact without leakage.
The dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels, and foam dressings.
The Hollister Transparent Wound Dressing is presented sterile and is available in a variety of sizes to accommodate various sizes of wounds.
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K Number
K992302Device Name
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-09-14
(68 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.
The following indications for use are for Prescription and Over-the-Counter Use:
Dermaphylyx Skin Protectors are intended for the prevention of:
- Blisters .
- Friction Burns .
Device Description
Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.
Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.
The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability
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K Number
K992005Device Name
GILTECH PLUS TRANSPARENT DRESSING
Manufacturer
GILTECH PLUS, INC.
Date Cleared
1999-09-03
(80 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:
(a) Stage I and II pressure sores (decubitus ulcers)
(b) Skin tears or lacerations
(c) Superficial burns and abrasions
(d) Surgical wounds
Device Description
Transparent Dressing
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K Number
K990875Device Name
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-05-27
(72 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following Indications are for Prescription Use or under the direction of a health care professional:
Dermal Ulcers
Donor Sites
Incisions
Superficial Burns
Abrasions and lacerations
IV Catheter Sites
The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Blisters
As a Cover for gauze and gel bandages.
Device Description
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. The wound contact surface is composed of a porous adhesive. A second layer consists of a polyurethane film which is waterproof and dirt proof while maintaining breathability.
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K Number
K990438Device Name
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-03-25
(42 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears
The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters
Device Description
Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive. Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable. The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability
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K Number
K984371Device Name
MEPITEL NON ADHERENT SILICONE DRESSING
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
1999-03-03
(86 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Product Code :
MGP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.
Device Description
Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).
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