Catalog number is unknown.Udi information is unknown.Lot number is unknown.Operator of device: is unknown.Initial reporter also sent report to fda is unknown.Premarket (510k) number is unknown.No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
|