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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Ruby Coil LP, 5 mm x 10 cm
PENUMBRA, INC.
RBYLP0510-B
In Commercial Distribution

  • 00815948026063 ()


  • Neurovascular embolization coil
  • Non-neurovascular embolization coil
Ruby Coil LP, 4 mm x 15 cm
PENUMBRA, INC.
RBYLP0415-B
In Commercial Distribution

  • 00815948026049 ()


  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Ruby Coil LP, 4 mm x 6 cm
PENUMBRA, INC.
RBYLP0406-B
In Commercial Distribution

  • 00815948026032 ()


  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Ruby Coil LP, 2 mm x 10 cm
PENUMBRA, INC.
RBYLP0210
In Commercial Distribution

  • 00815948021761 ()


  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Ruby Coil LP, 2 mm x 2 cm
PENUMBRA, INC.
RBYLP0202
In Commercial Distribution

  • 00815948021747 ()


  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Ruby Coil LP, 1 mm x 2 cm
PENUMBRA, INC.
RBYLP0102
In Commercial Distribution

  • 00815948021723 ()


  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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
OPTI0156BLK
In Commercial Distribution

  • 00810068568875 ()

  • 1.5mm x 6cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil
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
OPTI0153BLK
In Commercial Distribution

  • 00810068568868 ()

  • 1.5mm x 3cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil
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
OPTI0103BLK
In Commercial Distribution

  • 00810068568851 ()

  • 1mm x 3cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil
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
OPTI1265BLK
In Commercial Distribution

  • 00810068568844 ()

  • 12mm x 65cm (Secondary Diameter x Length)
N/A

  • Neurovascular embolization coil
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