Additional information was added to h3, h4 and h6.H4: the device was manufactured from december 11, 2020 - december 14, 2020.Additional information was added to h3, h4 and h6.D9: corrected information, the device was not received for evaluation.H4: the device was manufactured from december 11, 2020 - december 14, 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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