Device |
uv curing |
Definition |
An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc. |
Product Code | RGO |
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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