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U.S. Department of Health and Human Services

Product Classification
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Device hemostatic wound dressing with thrombin or other biologics
Definition To temporarily control bleeding and cover external wounds.
Physical State Commonly a solid sheet, powder form or semi-solid form impregnated with thrombin or other biologics involved in the blood clotting process.
Technical Method Blood clotting by the biological action of thrombin and action of clotting cascade activated by thrombin or other biologics.
Target Area Topical wounds
Review Panel General & Plastic Surgery
Product CodeQSX
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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