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June 2017 URGENT MEDICAL DEVICE FIELD SAFETY NOTICE Atrium Advance V12 Balloon Expandable Covered Stent 7 mm x 22 mm x 120 cm Part Number 85355 Lot Number 240734 IMPROPER SIZE LABELING ON DEVICE MANIFOLD
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To fill out the urgent medical device field, follow these steps:
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Access the form or platform where you need to fill out the field.
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Locate the section or field labeled 'Urgent Medical Device'.
04
Ensure you have all the necessary information regarding the medical device that needs to be addressed urgently.
05
Begin filling out the field by providing relevant details about the medical device.
06
Include information such as the device name, model number, manufacturer, and any other specific identifiers.
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If applicable, enter additional details like the purpose or function of the medical device.
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Double-check the accuracy of the provided information before proceeding.
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Save or submit the form once you have completed filling out the urgent medical device field.
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Who needs urgent medical device field?
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The urgent medical device field is typically needed by:
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- Healthcare professionals and practitioners who encounter emergency situations where immediate attention or access to a particular medical device is required.
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- Medical device manufacturers or suppliers who need to address urgent inquiries or requests related to their products.
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- Regulatory authorities or agencies responsible for monitoring and ensuring the safety and availability of medical devices.
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- Emergency response teams or organizations involved in providing medical assistance during critical situations.
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This field helps to prioritize and address urgent medical device needs efficiently.
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What is urgent medical device field?
Urgent medical device field is a section in regulatory submissions where information about medical devices requiring immediate attention or action is provided.
Who is required to file urgent medical device field?
Manufacturers, importers, and distributors of medical devices are required to file urgent medical device field.
How to fill out urgent medical device field?
The urgent medical device field should be filled out with detailed information about the device, the urgency of the situation, and any actions taken or recommended.
What is the purpose of urgent medical device field?
The purpose of urgent medical device field is to ensure prompt communication and response to medical devices that pose a risk to public health.
What information must be reported on urgent medical device field?
Information such as device identification, reason for urgency, impact on patient safety, and recommended actions must be reported on urgent medical device field.
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