Product Classification

• Device: metal halide lamp, other
• Definition: Any metal halide lamp, including sodium vapor, that does not incorporate a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope.
• Product Code: RIH
• 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