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 unclean (e.g. a broken seal or ripped or torn packaging). (Food and Drug Administration)

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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.

Device Out of Bounds Error Evaluation Result

The device software attempted to write data outside the allowed memory location.

Device or Device Component Manufacturing

A process that involves designing, fabrication, assembly and/or processing of a device or device component.