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510(k) Data Aggregation
K Number
K041059Device Name
EPI-MAX
Manufacturer
Date Cleared
2005-05-17
(389 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.
Device Description
Epi-Max is a cellulose acetate mesh wound dressing (initially in a 2 x 3 in2 size but later with smaller or larger sizes as per market demand) impregnated with 20mg of a petrolatum (polyethylene glycol-based) ointment. This ointment is a blend of PEG 400, PEG 4000, citric acid, a mild proprietary saline solution, and benzoic acid. The ointment is formulated to melt at skin temperature, helping to keep the wound moist and prevent wound-bandage adherence in order to make removal of the wound dressing less painful. Dressings are gamma irradiated for sterility.
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