Your ultrasound probes may not be required to be marked directly. Only devices which require high-level disinfection (using a sterilant) between uses require direct part marking. If your ultrasound probes only require low-level disinfection between uses, then direct part marking is not required.
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Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
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Original Message:
Sent: 16-Aug-2018 22:40
From: Rashmi Pillay
Subject: UDI Direct marking
Hi,
Has anybody done direct marking for ultrasound probes , what method did you use for direct marking?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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