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U.S. Department of Health and Human Services

Product Classification
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Device cold-cathode gas discharge tubes
Definition An electronic device in which electron flow is produced and sustained by ionization of contained gas and ion bombardment of the cathode.
Product CodeRBJ
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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