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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 - 00818053025549

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
OPTI0620HSFMX
In Commercial Distribution

  • 00818053025549 ()

  • Helical OptiMAX Soft - 6mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025532

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
OPTI0615HSFMX
In Commercial Distribution

  • 00818053025532 ()

  • Helical OptiMAX Supersoft - 6mm x 15cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025525

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
OPTI0520HSFMX
In Commercial Distribution

  • 00818053025525 ()

  • Helical OptiMAX Soft - 5mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025518

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
OPTI0515HSFMX
In Commercial Distribution

  • 00818053025518 ()

  • Helical OptiMAX Soft - 5mm x 15cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025501

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
OPTI0420HSSMX
In Commercial Distribution

  • 00818053025501 ()

  • Helical OptiMAX Soft - 4mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025495

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
OPTI0412HSFMX
In Commercial Distribution

  • 00818053025495 ()

  • Helical OptiMAX Soft - 4mm x 12cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025488

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
OPTI0410HSFMX
In Commercial Distribution

  • 00818053025488 ()

  • Helical OptiMAX Soft - 4mm x 10cm
N/A

  • Neurovascular embolization coil

ULTRA Detach - 00818053029639

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

  • 00818053029639 ()


  • Vascular implant detacher, electronic, single-use

Prestige Coil System - 00818053027758

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
PRES0510COM18
In Commercial Distribution

  • 00818053027758 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027741

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
PRES0620HPK10
In Commercial Distribution

  • 00818053027741 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil
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