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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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Prestige Coil System - 00818053027505

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
PRES0517CPKPL
In Commercial Distribution

  • 00818053027505 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027482

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
PRES0507CPKPL
In Commercial Distribution

  • 00818053027482 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027475

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
PRES4510CPKPL
In Commercial Distribution

  • 00818053027475 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027451

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
PRES0413CPKPL
In Commercial Distribution

  • 00818053027451 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027437

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
PRES0407CPKPL
In Commercial Distribution

  • 00818053027437 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027420

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
PRES0404CPKPL
In Commercial Distribution

  • 00818053027420 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00818053027383

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
PRES0310CXPPL
In Commercial Distribution

  • 00818053027383 ()

  • PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm


  • Non-neurovascular embolization coil

Optima Coil System - 00818053027024

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
OPTI0620HST10
In Commercial Distribution

  • 00818053027024 ()

  • Helical-10 Standard 6mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053027000

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
OPTI0610HSF10
In Commercial Distribution

  • 00818053027000 ()

  • Helical Soft - 6mm x 20cm
N/A

  • Neurovascular embolization coil

Optima Coil System - 00818053026973

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
OPTI0606HSF10
In Commercial Distribution

  • 00818053026973 ()

  • Helical Soft 6mm x 6cm
N/A

  • Neurovascular embolization coil
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