Except under specific circumstances (specific regulatory requirements), the labeller shall decide the appropriate PI(s) (Production Identifier) for a device. If the device is intended to be used more than once and intended to be reprocessed before each use then a Direct Part Marking process would be required.
GS1 would recommend marking using a GS1 DataMatrix with GTIN and serial number as an appropriate approach. See section 2.1.8 of the GS1 General Specifications on Medical devices (non-retail trade items) for more details.
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