Device Packaging Verification Evaluation Method

Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable microorganisms. (Food and Drug Administration)

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Device Packaging Problem Evaluation Result

Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents). …

Device Packaging Compromised Evaluation Result Evaluation Result

Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or…

Device Packaging Compromised

Issue associated with the non-conformance to device specifications and minimum packaging requirements as the device may not be operating and functioning as…

Device Package Insert Problem Evaluation Result

Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect…

Device Overcurrent Protection Testing Evaluation Method

Testing the device's over-current protection circuitry for its response to situations of overload, short circuit, or ground fault.

Device Over The Counter Product Indicator

Specifies whether a device is available over-the-counter.