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510(k) Data Aggregation
K Number
K051542Device Name
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
Manufacturer
Date Cleared
2006-03-17
(280 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIOSYN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40™ Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.
Device Description
The Triosyn T40'''' Antimicrobial Wound Dressing is a sterile, primary wound dressing. It is a multi-layer composite dressing consisting of an absorbent polycster non-woven pad, a permeable adhesive, a single layer of Triosyn iodinated resin beads, and a non-adherent high-density polyethylene mesh (HDPE). This non-adhesive composite dressing is designed to be used as a barrier against microbial penetrations and as a method to reduce the microbial load in partial and full thickness wounds'.
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