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510(k) Data Aggregation
K Number
K160130Device Name
BloodSTOP iX Battle Matrix
Manufacturer
Date Cleared
2016-06-29
(161 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LifeSciencePLUS Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
Device Description
BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from cellulose. Using a proprietary process, regenerated cellulose is etherified and oxidized to make a watersoluble, hemostatic matrix. When applied to a wound, BloodSTOP® iX Battle Matrix absorbs blood and other body fluids, transforms into a gel, actively aids in blood coagulation, and adheres to the wound with a protective translucent layer. BloodSTOP iX exerts its pro-coagulant activity by activating the intrinsic coagulation pathway, accelerating clot formation. Its water solubility allows for easy removal through rinsing without disruption of the clotted wound surface. BloodSTOP iX Battle Matrix is provided sterile in a simple to use format that readily conforms to a wound: 3"x24" strip, z-folded to an 8-layer 3"x3" pad.
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