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510(k) Data Aggregation
K Number
K063517Device Name
HEALADEX-P
Manufacturer
HEALAGENICS, INC.
Date Cleared
2007-02-16
(87 days)
Product Code
FRO, KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEALAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns
- Severe sunburns
- Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears
HEALADEX-P dressing should be used under health care professional direction for the following indications:
- Pressure ulcers, Stage I-IV
- Lower extremity ulcers
- Venous ulcers
- Arterial ulcers
- Ulcers of mixed etiology
- Diabetic ulcers
- Donor sites and skin grafts
- Burns caused by radiation oncology procedures
Device Description
HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site.
HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).
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