Additional information was added to d9, h3, h4, h6, h10.H4: the lot was manufactured between may 12, 2019 - may 14, 2019.H10: the device was received for evaluation.Unaided visual inspection was performed and observed primary packaging seal not sealed on the right side area.The reported condition was verified.The cause of the condition was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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