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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 - 00810068568806

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
OPTI0845BLK
In Commercial Distribution

  • 00810068568806 ()

  • 8mm x 45cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568790

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
OPTI0750BLK
In Commercial Distribution

  • 00810068568790 ()

  • 7mm x 50cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568783

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
OPTI0735BLK
In Commercial Distribution

  • 00810068568783 ()

  • 7mm x 35cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568776

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
OPTI0720BLK
In Commercial Distribution

  • 00810068568776 ()

  • 7mm x 20cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568769

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
OPTI0650BLK
In Commercial Distribution

  • 00810068568769 ()

  • 6mm x 50cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568752

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
OPTI0635BLK
In Commercial Distribution

  • 00810068568752 ()

  • 6mm x 35cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568745

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
OPTI0540BLK
In Commercial Distribution

  • 00810068568745 ()

  • 5mm x 40cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568738

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
OPTI0517BLK
In Commercial Distribution

  • 00810068568738 ()

  • 5mm x 17cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568721

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
OPTI0435BLK
In Commercial Distribution

  • 00810068568721 ()

  • 4mm x 35cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil

Optima Coil System - 00810068568714

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
OPTI0420BLK
In Commercial Distribution

  • 00810068568714 ()

  • 4mm x 20cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil
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