If you do some digging it seems that this co has run into trouble with FDA and have rebranded from Shelhigh to Biointegral not long after.
https://www.law360.com/health/articles/22913/fda-seizes-products-from-device-maker
https://academic.oup.com/ejcts/arti...seudoaneurysm-formation-in-the-Biointegral-No
If you do some digging it seems that this co has run into...
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