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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 - 00818053026447

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
OPTI0827COM18
In Commercial Distribution

  • 00818053026447 ()

  • Complex-18 8mm x 27cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053026430

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
OPTI0724COM18
In Commercial Distribution

  • 00818053026430 ()

  • Complex-18 7mm x 24cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053026423

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
OPTI0620COM18
In Commercial Distribution

  • 00818053026423 ()

  • Complex-18 6mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053026553

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
OPTI2265COM18
In Commercial Distribution

  • 00818053026553 ()

  • Complex-18 22mm x 65cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053026539

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
OPTI1860COM18
In Commercial Distribution

  • 00818053026539 ()

  • Complex-18 18mm x 60cm
N/A

  • Neurovascular embolization coil

TRUFILL DCS ORBIT - 10886704029946

TRUFILL DCS ORBIT Detachable Coil 175cm 3.5mm x 9cm Coil Type: Mini Complex Fill
Cerenovus, Inc.
637MF3509
Not in Commercial Distribution

  • 10886704029946 ()
637MF3509

  • Neurovascular embolization coil

TRUFILL DCS ORBIT - 10886704029922

TRUFILL DCS ORBIT Detachable Coil 175cm 2.5mm x 4.5cm Coil Type: Mini Complex Fill
Cerenovus, Inc.
637MF2545
Not in Commercial Distribution

  • 10886704029922 ()
637MF2545

  • Neurovascular embolization coil

TRUFILL DCS ORBIT - 10886704029908

TRUFILL DCS ORBIT Detachable Coil 175cm 2.5mm x 2.5cm Coil Type: Mini Complex Fill
Cerenovus, Inc.
637MF2525
Not in Commercial Distribution

  • 10886704029908 ()
637MF2525

  • Neurovascular embolization coil

TRUFILL DCS ORBIT - 10886704029885

TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 7cm Coil Type: Mini Complex Fill
Cerenovus, Inc.
637MF0407
Not in Commercial Distribution

  • 10886704029885 ()
637MF0407

  • Neurovascular embolization coil

TRUFILL DCS ORBIT - 10886704029861

TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 6cm Coil Type: Mini Complex Fill
Cerenovus, Inc.
637MF0306
Not in Commercial Distribution

  • 10886704029861 ()
637MF0306

  • Neurovascular embolization coil
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