Icon
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Action
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Description
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New UDI
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Click this icon to create a UDI Super Set. For more information, see Creating a UDI.
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Copy Selected Object
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Copy a part to the clipboard to be used in a subsequent paste operation.
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> > |
Create a new change notice. The change notice includes an implementation plan detailing the tasks required to make the change. For more information, see Creating a Change Notice.
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> > |
Create a new review to validate the requirement.
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> > |
Create a new problem report to document a problem or request a product enhancement. For more information, see Creating a Problem Report.
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> |
Create a new change request. For more information, see Creating a Change Request
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> > |
Create a new variance in the folder. For more information, see Creating a Variance.
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The non-revisable UDI Super Set is not a changeable object. If you select multiple UDI Super Sets including revisable and non-revisable, for creating a change object, then only revisable UDI Super Set will get added in the Affected Objects table.
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You can create change objects (change notice, change request, problem report, variance, and review) only for the revisable UDI super set.
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Action
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Description
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> |
Create a new change notice.
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> |
Create a new review to validate the requirement.
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> |
Create a new problem report to document a problem or request a product enhancement. For more information, see About Design Reviews.
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> |
Create a new variance in the folder.
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> |
Create a new change request.
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Attribute
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Description
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General Status
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Status of the Super Set object. If the object is checked out, this column displays an icon indicating that the object is checked out.
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Change Status
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It displays an icon after the object is checked in.
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Object Type Indicator
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It displays an icon indicating the type of the object. The types of objects are: UDI Super Set and UDI Super Set (Revisable).
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Identity
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Current version and number of the object. Click on this number to view the UDI Info page.
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Name
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Name of the object.
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Primary Device Identifier
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This number is the primary lookup for a medical device product.
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State
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Indicates the current state of the object. The object can be in one of the following states: Creation, Approval, Closed, and Canceled.
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Last Modified
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Date and time when the object was last modified.
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Context
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Current library the UDI is associated to.
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For revisable super sets, the information about the latest revision is displayed.
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