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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 - 00810068568707

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.
BALT USA LLC
OPTI0106BLK
In Commercial Distribution

  • 00810068568707 ()

  • 1mm x 6cm (Implant Size)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568691

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.
BALT USA LLC
OPTI1465BLK
In Commercial Distribution

  • 00810068568691 ()

  • 14mm x 65cm (Implant Size)
N/A

  • Neurovascular embolization coil

Prestige Coil System - 00810068568042

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
PRES1065HPKPL
In Commercial Distribution

  • 00810068568042 ()

  • PRESTIGE PLUS HELICAL PACK 10mm x 65cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068568028

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
PRES0540CPKPLT
In Commercial Distribution

  • 00810068568028 ()

  • PRESTIGE PLUS COMPLEX PACK 5mm x 40cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567878

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
PRES0865HPKPL
In Commercial Distribution

  • 00810068567878 ()

  • PRESTIGE PLUS HELICAL PACK 8mm x 65cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567861

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
PRES0750HPKPL
In Commercial Distribution

  • 00810068567861 ()

  • PRESTIGE PLUS HELICAL PACK 7mm x 50cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567854

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
PRES0650HPKPL
In Commercial Distribution

  • 00810068567854 ()

  • PRESTIGE PLUS HELICAL PACK 6mm x 50cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567847

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
PRES0540HPKPL
In Commercial Distribution

  • 00810068567847 ()

  • PRESTIGE PLUS HELICAL PACK 5mm x 40cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567830

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
PRES0440HPKPL
In Commercial Distribution

  • 00810068567830 ()

  • PRESTIGE PLUS HELICAL PACK 4mm x 40cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567823

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
PRES2465CPKPLT
In Commercial Distribution

  • 00810068567823 ()

  • PRESTIGE PLUS COMPLEX PACK 24mm x 65cm


  • Non-neurovascular embolization coil
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