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510(k) Data Aggregation
K Number
K063805Device Name
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
Manufacturer
Date Cleared
2007-07-13
(203 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NUCRYST PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Silcryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
Device Description
Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for topical application for external wound management. It aids the body by providing a moist wound environment optimal for healing. The cream also serves as a broad spectrum anti-microbial barrier. It is presented as a prescription product.
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