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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PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, T Shape
Medos International Sàrl
201-D
Not in Commercial Distribution

  • 00859030005154 ()
201-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 10 mm, T shape
Medos International Sàrl
211-D
Not in Commercial Distribution

  • 00859030005130 ()
211-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, Y shape
Medos International Sàrl
301-D
Not in Commercial Distribution

  • 00859030005116 ()
301-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 10 mm, Y shape
Medos International Sàrl
311-D
Not in Commercial Distribution

  • 00859030005093 ()
311-D

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 10 mm, Y shape
Medos International Sàrl
313-D
Not in Commercial Distribution

  • 00859030005086 ()
313-D

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 37mm. 12mm Distal tip. Maximum Stent foreshortening 4.7mm, Recommended Microcatheter .021inch(0.533mm)
Medos International Sàrl
ENF453712
Not in Commercial Distribution

  • 10886704044048 ()
ENF453712

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 28mm. 12mm Distal tip. Maximum Stent foreshortening 3.2mm, Recommended Microcatheter .021inch(0.533mm)
Medos International Sàrl
ENF452812
Not in Commercial Distribution

  • 10886704044031 ()
ENF452812

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 22mm. 12mm Distal tip. Maximum Stent foreshortening 1.9mm, Recommended Microcatheter .021inch(0.533mm)
Medos International Sàrl
ENF452212
Not in Commercial Distribution

  • 10886704044024 ()
ENF452212

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm. 12mm Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm)
Medos International Sàrl
ENF451412
Not in Commercial Distribution

  • 10886704044017 ()
ENF451412

  • Bare-metal intracranial vascular stent
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
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