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    RE: UDI Primary DI Number

    The sealed tray and the shelf box get the same DI. This is not a Unit of Use case since the base package quantity is one. This is not a packaging configuration, since the quantity is one. (A, so called, one-in-a-one, is not a packaging configuration.) The one piece box and the five piece box are not shipping containers under the UDI rule,...

  • The problem is that OTC/Rx is not a device attribute listed as part of the classification page. For 510(k) devices, one must read the clearance letter. I’ve seen the same device by Product Code with different OTC/RX classifications in different clearance letters. However, I believe that that a home use HIV test kit, Product Code MVZ,...

  • Good morning, we know that Health Canada require medical device manufacturers to file a yearly notification of license renewal details, regardless of whether the design of the devices covered by the license has been modified with a significant change during the previous year. The manufacturer is required to notify Health Canada with any non-significant...

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