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U.S. Department of Health and Human Services

Product Classification

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Device temporary, internal use hemostatic
Regulation Description Non-absorbable, hemostatic gauze for temporary internal use.
Definition Intended to control severely bleeding wounds
Physical State Hemostatic agent either alone or incorporated into/onto another material, e.g. gauze.
Technical Method Proposed hemostatic mechanisms of action include physical tamponade, water absorption, and mechanical sealing.
Target Area Indicated for use for severely bleeding wounds such as surgical wounds and traumatic injuries, including organ space bleeding.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePOD
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4454
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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