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U.S. Department of Health and Human Services

Product Classification
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Device eua faceshields
Definition Authorized faceshields intended for use during the declared public health emergency.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel General Hospital
Product CodeQPK
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type Enforcement Discretion
Device Class Not Classified
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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