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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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Optima Coil System - 00818053024764

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
OPTI0412CSS10
In Commercial Distribution

  • 00818053024764 ()

  • Complex Supersoft - 4mm x 12cm


  • Neurovascular embolization coil

Optima Coil System - 00818053024757

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
OPTI0258CSS10
In Commercial Distribution

  • 00818053024757 ()

  • Complex Supersoft - 2.5mm x 8cm


  • Neurovascular embolization coil

Optima Coil System - 00818053024740

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
OPTI0210CSS10
In Commercial Distribution

  • 00818053024740 ()

  • Complex Supersoft - 2mm x 10cm


  • Neurovascular embolization coil

Optima Coil System - 00818053024733

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
OPTI0410CSF10
In Commercial Distribution

  • 00818053024733 ()

  • Complex Soft - 4mm x 10cm
N/A

  • Neurovascular embolization coil

ULTRA Detach - 00818053024351

The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system.
BALT USA LLC
ULTRA
In Commercial Distribution

  • 00818053024351 ()


  • Vascular implant detacher, electronic, single-use

Optima Coil System - 00818053024344

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
PRES1030HRG10
In Commercial Distribution

  • 00818053024344 ()

  • Helical 10 Regular 10mm x 30cm


  • Non-neurovascular embolization coil

Optima Coil System - 00818053024337

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
PRES0930HRG10
In Commercial Distribution

  • 00818053024337 ()

  • Helical 10 Regular 9mm x 30cm


  • Non-neurovascular embolization coil

Optima Coil System - 00818053024320

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
PRES0830HRG10
In Commercial Distribution

  • 00818053024320 ()

  • Helical 10 Regular 8mm x 30cm


  • Non-neurovascular embolization coil

Optima Coil System - 00818053024313

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
PRES0820HRG10
In Commercial Distribution

  • 00818053024313 ()

  • Helical 10 Regular 8mm x 20cm


  • Non-neurovascular embolization coil

Optima Coil System - 00818053024306

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
PRES0730HRG10
In Commercial Distribution

  • 00818053024306 ()

  • Helical 10 Regular 7mm x 30cm


  • Non-neurovascular embolization coil
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