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510(k) Data Aggregation
K Number
K080648Device Name
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
Manufacturer
Date Cleared
2008-05-07
(61 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ORE-MEDIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prescription Use: TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe bleeding.
Over the Counter Use: TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Device Description
TRAUMASTAT™ Hemostatic Wound Dressing is a unique non-woven substrate comprised of porous polyethylene fibers highly filled with precipitated silica. This substrate is coated with chitosan, manufactured from ChitoClear™, a material consisting of the cellulosic polymer, poly-N-acctylglucosamine which is generally recognized as safe in accordance with 21 CFR 170,30. Each fiber of the wound dressing is approximately 20 to 100 micrometers in diameter. The wound dressing is provided in multiple lengths and widths to accommodate varying clinical situations as appropriate for its intended use. The dressing thickness is approximately 3 mm with an average density of approximately 0.15 gram/cc.
TRAUMATAT Hemostatic Wound Dressing is hermetically sealed in a poly foil pouch and electron beam sterilized.
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