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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Airway Sizing Kit
Gyrus Acmi, Llc
HUS-VSK
In Commercial Distribution

  • 00896506002217 ()


  • Endobronchial airway sizing kit
Valve in Cartridge, 9mm
Gyrus Acmi, Llc
HUS-V9
In Commercial Distribution

  • 00896506002200 ()

  • Outer Diameter: 9 Millimeter


  • Endobronchial valve
Deployment Catheter and Loader, 2.6
Gyrus Acmi, Llc
HUS-C26N
In Commercial Distribution

  • 00896506002187 ()


  • Endobronchial valve delivery catheter
Airway Sizing Kit
Gyrus Acmi, Llc
HUS-SK
In Commercial Distribution

  • 00896506002125 ()


  • Endobronchial airway sizing kit
Deployment Catheter and Loader, 2.6
Gyrus Acmi, Llc
HUS-C26
In Commercial Distribution

  • 00896506002118 ()


  • Endobronchial valve delivery catheter
Valve in Cartridge, 7mm
Gyrus Acmi, Llc
HUS-V7
In Commercial Distribution

  • 00896506002101 ()

  • Outer Diameter: 7 Millimeter


  • Endobronchial valve
Valve in Cartridge, 6mm
Gyrus Acmi, Llc
HUS-V6
In Commercial Distribution

  • 00896506002095 ()

  • Outer Diameter: 6 Millimeter


  • Endobronchial valve
Valve in Cartridge , 5mm
Gyrus Acmi, Llc
HUS-V5
In Commercial Distribution

  • 00896506002088 ()

  • Outer Diameter: 5 Millimeter


  • Endobronchial valve
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
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