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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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The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0840
In Commercial Distribution

  • 04540778177154 ()

  • Complex (Soft) 14inch 8mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0840

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0730
In Commercial Distribution

  • 04540778177123 ()

  • Complex (Soft) 12inch 7mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0730

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0620
In Commercial Distribution

  • 04540778177093 ()

  • Complex (Soft) 12inch 6mm x 20cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0620

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0515
In Commercial Distribution

  • 04540778177079 ()

  • Complex (Soft) 12inch 5mm x 15cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0515

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0510
In Commercial Distribution

  • 04540778177055 ()

  • Complex (Soft) 12inch 5mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0510

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0410
In Commercial Distribution

  • 04540778177048 ()

  • Complex (Soft) 10inch 4mm x 10cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0410

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-03H8
In Commercial Distribution

  • 04540778177017 ()

  • Complex (Extra Soft) 10inch 3.5mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-03H8

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0306
In Commercial Distribution

  • 04540778176997 ()

  • Complex (Extra Soft) 10inch 3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0306

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0304
In Commercial Distribution

  • 04540778176980 ()

  • Complex (Extra Soft) 10inch 3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093
In Commercial Distribution

  • 00650551050100 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-093

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode
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