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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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StarClose SE™ - 08717648175060

StarClose SE™ Vascular Closure System
ABBOTT VASCULAR INC.
14679-05
In Commercial Distribution

  • 08717648175060 ()
  • 28717648175064 ()
14679-05

  • Implantable vascular closure clip

StarClose SE™ - 08717648079467

StarClose SE™ Vascular Closure System
ABBOTT VASCULAR INC.
14679-01
In Commercial Distribution

  • 28717648079461 ()
  • 08717648079467 ()
14679-01

  • Implantable vascular closure clip

Optima Coil System - 00818053025471

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
OPTI0315HSSMX
In Commercial Distribution

  • 00818053025471 ()

  • Helical OptiMAX Supersoft - 3mm x 15cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025464

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
OPTI0310HSSMX
In Commercial Distribution

  • 00818053025464 ()

  • Helical OptiMAX Supersoft - 3mm x 10cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025457

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
OPTI2535HSSMX
In Commercial Distribution

  • 00818053025457 ()

  • Helical OptiMAX Supersoft - 2.5mm x 3.5cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025440

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
OPTI2525HSSMX
In Commercial Distribution

  • 00818053025440 ()

  • Helical OptiMAX Supersoft - 2.5mm x 2.5cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025433

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
OPTI0204HSSMX
In Commercial Distribution

  • 00818053025433 ()

  • Helical OptiMAX Supersoft - 2mm x 4cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025426

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
OPTI0202HSSMX
In Commercial Distribution

  • 00818053025426 ()

  • Helical OptiMAX Supersoft - 2mm x 2cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053025419

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
OPTI0153HSSMX
In Commercial Distribution

  • 00818053025419 ()

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

  • Neurovascular embolization coil

Optima Coil System - 00818053025402

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
OPTI1515HSSMX
In Commercial Distribution

  • 00818053025402 ()

  • Helical OptiMAX Supersoft - 1.5mm x 1.5cm
N/A

  • Neurovascular embolization coil
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