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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.
BALT USA LLC
OPTI0153CSSMX
In Commercial Distribution

  • 00818053024962 ()

  • Complex OptiMAX Supersoft - 1.5mm x 3cm
N/A

  • Neurovascular embolization coil
The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.
BALT USA LLC
OPTI0152CSSMX
In Commercial Distribution

  • 00818053024955 ()

  • Complex OptiMAX Supersoft - 1.5mm x 2cm
N/A

  • Neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0206HXP10
In Commercial Distribution

  • 00818053023996 ()

  • Helical 10 Xtra Pack 2mm x 6cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0204HXP10
In Commercial Distribution

  • 00818053023989 ()

  • Helical 10 Xtra Pack 2mm x 4cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0203HXP10
In Commercial Distribution

  • 00818053023972 ()

  • Helical 10 Xtra Pack 2mm x 3cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0202HXP10
In Commercial Distribution

  • 00818053023965 ()

  • Helical 10 Xtra Pack 2mm x 2cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0201HXP10
In Commercial Distribution

  • 00818053023958 ()

  • Helical 10 Xtra Pack 2mm x 1cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0154HXP10
In Commercial Distribution

  • 00818053023941 ()

  • Helical 10 Xtra Pack 1.5mm x 4cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0153HXP10
In Commercial Distribution

  • 00818053023934 ()

  • Helical 10 Xtra Pack 1.5mm x 3cm


  • Non-neurovascular embolization coil
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0152HXP10
In Commercial Distribution

  • 00818053023927 ()

  • Helical 10 Xtra Pack 1.5mm x 2cm


  • Non-neurovascular embolization coil
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