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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Brainlab AG
18099-24
In Commercial Distribution

  • 04056481004804 ()
18099-24

  • Electromagnetic surgical navigation device tracking system
Navigation station of the IMACTIS® CT-NAVIGATION system
IMACTIS
J02000
In Commercial Distribution

  • B681J020000 ()
MA-J02000

  • Electromagnetic surgical navigation device tracking system
Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system
IMACTIS
J00197
In Commercial Distribution

  • B681J001971 ()


  • Electromagnetic surgical navigation device tracking system
Power cable of the IMACTIS® CT-NAVIGATION system
IMACTIS
J00099_US
In Commercial Distribution

  • B681J00099US0 ()
MA-J00099_US

  • Electromagnetic surgical navigation device tracking system
Single use Navigation Kit of the IMACTIS® CT-NAVIGATION system
IMACTIS
I10100
In Commercial Distribution

  • B681I101002 ()
MA-I10100

  • Electromagnetic surgical navigation device tracking system
Non-sterile needle holder of the IMACTIS® CT-NAVIGATION system
IMACTIS
A10200
In Commercial Distribution

  • B681A102001 ()


  • Electromagnetic surgical navigation device tracking system
Sterile needle holder of the IMACTIS® CT-NAVIGATION system
IMACTIS
A10010
In Commercial Distribution

  • B681A100101 ()


  • Electromagnetic surgical navigation device tracking system
Sensor Interface Unit (SIU)
BOSTON SCIENTIFIC CORPORATION
M004RH22000
In Commercial Distribution

  • 08714729842101 ()


  • Electromagnetic surgical navigation device tracking system
System Control Unit (SCU)
BOSTON SCIENTIFIC CORPORATION
M004RH21000
In Commercial Distribution

  • 08714729842095 ()


  • Electromagnetic surgical navigation device tracking system
Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20000
In Commercial Distribution

  • 08714729842088 ()


  • Electromagnetic surgical navigation device tracking system
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