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510(k) Data Aggregation
K Number
K082601Device Name
UltraClot, UltraClot OTC
Manufacturer
EMERGENCY MEDICAL DEVICES, LLC
Date Cleared
2008-10-09
(31 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EMERGENCY MEDICAL DEVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription, Rx UltraClot™ is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding.
Over the Counter, OTC
UltraClot™ OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
Device Description
UltraClot™ is a hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing that is placed on a moderate to severe wound and held in place until hemostasis is achieved. The device is packaged in a vacuum sealed foil bag and is provided sterile.
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