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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Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-006-R
Not in Commercial Distribution

  • 00856264005721 ()
014003

  • Retinal prosthesis system tester/clinical evaluator
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-004-R
Not in Commercial Distribution

  • 00856264005394 ()
014003

  • Retinal prosthesis system tester/clinical evaluator
External USB Drive for archiving of files from the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014931-001
Not in Commercial Distribution

  • 00856264005455 ()
014931

  • Retinal prosthesis system tester/clinical evaluator
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 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
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.0 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
ENF402312
In Commercial Distribution

  • 10886704075356 ()
ENF402312

  • Bare-metal intracranial vascular stent
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 1.2 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
ENF401612
In Commercial Distribution

  • 10886704075332 ()
ENF401612

  • Bare-metal intracranial vascular stent
5-pack FENIX Tape Sizer
Torax Medical, Inc.
FXTS
Not in Commercial Distribution

  • 00855106005462 ()
  • 00855106005455 ()


  • Anal sphincter prosthesis
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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