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510(k) Data Aggregation
K Number
K140573Device Name
WOUNDCLOT HEMOSTATIC GAUZE
Manufacturer
Date Cleared
2014-11-24
(263 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CORE SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.
Device Description
Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.
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