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Barcode (UDI): 00843889043894
Catalog No: PC-2-2-HELIX
Product Type: Medical Device
GMDN: Neurovascular embolization coil (60940)
Regulation: 93/42/EEC
Description: A sterile, non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.