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Found 9 results
510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
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
K991920Device Name
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-08-12
(66 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Burns, (superficial)
Abrasions and lacerations
Incisions
Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.
The following indications for use are for Over-the-Counter Use:
Minor Burns
Minor cuts
Minor abrasions
Minor lacerations
Device Description
Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive. Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.
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K Number
K991933Device Name
DERMAPHYLYX FOAM ISLAND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-07-30
(52 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991608Device Name
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-07-20
(71 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound.
The following Indications are for Prescription Use or under the direction of a health care professional:
- Venous ulcers
- Diabctic ulcers
- Pressure ulcers
- Ancrial ulcers
- Superficial burns
- Abrasions and laccrations
- Donor sites
- Postoperative wounds
The following Indications are for Over-the-Counter Usc:
- Abrasions
- Minor Burns
- Minor Cuts
- Minor Laccrations
Device Description
Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.
Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.
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K Number
K991609Device Name
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-07-20
(71 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,
The following Indications are for Prescription Use or under the direction of a health care professional:
Venous ulcers
Diabetic ulcers
Pressure ulcers
Arterial ulcers
Superficial burns
Abrasions and lacerations
Donor sites
Incisions
The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Device Description
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.
Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.
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K Number
K991061Device Name
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-06-28
(90 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding.
The following Indications are for Prescription Use or under the direction of a health care professional:
- Venous ulcers
- Diabctic ulcers
- Pressure ulcers
- Arterial ulcers
- Superficial burns
- Abrasions and lacerations
- Donor sites
- Postoperative wounds
The following Indications are for Over-the-Counter Use:
- Abrasions
- Minor Burns
- Minor Cuts
- Minor Lacerations
Device Description
Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.
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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?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
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
K990891Device Name
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-05-27
(71 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Hydrocolloid 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:
Venous stasis ulcers Diabetic ulcers Pressure sores Blisters
Superficial burns Abrasions and laccrations Donor sites
The following Indications are for Over-the-Counter Use:
Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters
Device Description
Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive.
The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt 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?
Applicant Name (Manufacturer) :
DERMAPHYLYX, INC.
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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