1be8bcd9-ce2d-4f6e-acdc-585a793ea049UpdatePublished52021-02-052018-02-21In Commercial DistributionM20638240PrimaryHIBCCGel-Bead™ Embolization Spheres3824008999906Vascular Solutions, Inc.1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse888-240-6001customerservice@vasc.com60892Non-neurovascular embolization plug, animal-derivedA bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.trueActiveKRDDevice, Vascular, For Promoting EmbolizationDevice Size Text, specifySphere Size 600-800 μm truefalse