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510(k) Data Aggregation
K Number
K122634Device Name
IODOFOAM IODOPHOR FOAM DRESSING
Manufacturer
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
Date Cleared
2013-03-12
(195 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Device Description
Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted
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