H4: device manufacture date: june 19, 2020 - june 23, 2020.H10: the device was received for evaluation.Unaided eye visual inspection was performed and the primary packaging seal was found not sealed on the right side only.The reported issue was verified of the primary packaging that was received with the right side seal opened approximately 5.0 inches.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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