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U.S. Department of Health and Human Services

Product Classification
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Device metal halide lamp
Definition High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a fill consisting of mercury and that is contained within an outer envelope.
Product CodeRDY
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Ineligible
Third Party Review Not Third Party Eligible
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