Device |
high pressure mercury, metal halide, and mercury xenon lamp (not for general purpose illumination) |
Definition |
A high pressure mercury vapor, metal halide, or mercury xenon lamp used for a specific purpose and not intended for general purpose illumination. Specific examples are lamps used in scientific and industrial equipment, projection televisions and computer projectors, searchlights, etc. |
Product Code | RHC |
Device Class |
Not Classified
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Total Product Life Cycle (TPLC) |
TPLC Product Code Report
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GMP Exempt? |
Yes
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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. |
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Summary Malfunction Reporting |
Ineligible |
Third Party Review |
Not Third Party Eligible |
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