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510(k) Data Aggregation
K Number
K242758Device Name
Atrauman® Ag
Manufacturer
Hartmann USA, Inc.
Date Cleared
2024-12-09
(88 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Hartmann USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.
Device Description
Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
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