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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VALVE PB1018 MELODY TPV HDE
MEDTRONIC, INC.
PB1018
Not in Commercial Distribution

  • 00643169415874 ()

  • Valve Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
VALVE PB1016 MELODY TPV HDE
MEDTRONIC, INC.
PB1016
Not in Commercial Distribution

  • 00643169415850 ()

  • Valve Size 16 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1022 ENSEMBLE HDE
MEDTRONIC, INC.
NU1022
Not in Commercial Distribution

  • 00643169415768 ()

  • Outer Balloon Size 22 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1020 ENSEMBLE HDE
MEDTRONIC, INC.
NU1020
Not in Commercial Distribution

  • 00643169415744 ()

  • Outer Balloon Size 20 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1018 ENSEMBLE HDE
MEDTRONIC, INC.
NU1018
Not in Commercial Distribution

  • 00643169415720 ()

  • Outer Balloon Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
LEAD 3391S-40 DBS HDE EMAN NO SCRNR CBL
MEDTRONIC, INC.
3391S-40
Not in Commercial Distribution

  • 00643169516786 ()

  • Length: 40.0 Centimeter


  • Deep brain electrical stimulation system
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 NO DISTAL TIP Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 4.3 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF403900
In Commercial Distribution

  • 10886704075400 ()
ENF403900

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 4.3 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF403912
In Commercial Distribution

  • 10886704075394 ()
ENF403912

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 30 NO DISTAL TIP Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.8 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF403000
In Commercial Distribution

  • 10886704075387 ()
ENF403000

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 30 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.8 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF403012
In Commercial Distribution

  • 10886704075370 ()
ENF403012

  • Bare-metal intracranial vascular stent
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