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510(k) Data Aggregation
K Number
K080949Device Name
KERATEC WOUND DRESSINGS
Manufacturer
Date Cleared
2009-02-11
(314 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KERATEC LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as:
- first and second degree burns
- severe sunburns
- superficial injuries, cuts, abrasions and surgical wounds
The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:
- Pressure (stage I-IV) and venous stasis ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Donor sites and grafts
Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.
The Keratec Wound Dressings are not intended to be used on third degree burns.
Device Description
The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are designed as chronic wound treatment devices for dry to heavily exuding wounds. The Keratec Wound Dressings are sterile, single-use wound care dressings that include keratin proteins derived from sheep wool for use in moist wound management.
The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.
Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.
Kerafoam is a keratin film coated on a polyurethane foam substrate for use in multilayered advanced wound dressings. The keratin film is in matrix form with soluble keratin proteins. The Kerafoam product forms a gel when in contact with wound exudates. The Kerafoam provides the exudate management features of other advanced moist wound dressings.
Keraderm is open-celled foam derived from freeze-dried keratin protein. Keraderm is re-absorbed into the developing tissue without traumatic dressing changes. Keraderm provides a bio-absorbable "scaffold" for the rapid growth of new tissue in three dimensions. Keraderm is provided in an acellular form of keratin protein.
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