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510(k) Data Aggregation
K Number
K182680Device Name
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
Manufacturer
Date Cleared
2018-12-06
(71 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Exciton Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KerraContact® Ag Perf Advanced Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Device Description
Exciton Technologies Inc. has developed the exsalt® technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven spunlace polyester laminated with gray Delnet® HDPE mesh layers on both sides. Silver in the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing (KerraContact® Ag Perf) inhibits bacterial growth in the dressing for up to 7 days. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/ cm² (4.5% w/w). The KerraContact® Ag Perf has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
KerraContact® Ag Perf meets pyrogen limit specifications.
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