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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Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-FF-01
In Commercial Distribution

  • 05415067032195 ()
ENSITE-FF-01

  • Electromagnetic surgical navigation device tracking system
Link Sensor Enabled Link
ST. JUDE MEDICAL, INC.
H702475
In Commercial Distribution

  • 05415067024756 ()
H702475

  • Electromagnetic surgical navigation device tracking system
Module
ST. JUDE MEDICAL, INC.
H702473
In Commercial Distribution

  • 05415067024732 ()
H702473

  • Electromagnetic surgical navigation device tracking system
Module
ST. JUDE MEDICAL, INC.
H702470
In Commercial Distribution

  • 05415067024701 ()
H702470

  • Electromagnetic surgical navigation device tracking system
Field Frame
ST. JUDE MEDICAL, INC.
H702469
In Commercial Distribution

  • 05415067024695 ()
H702469

  • Electromagnetic surgical navigation device tracking system
No Description
MERIT MEDICAL SYSTEMS, INC.
00852205006109
In Commercial Distribution

  • 10852205006106 ()
  • 00852205006109 ()
SH-01/A

  • Electromagnetic surgical navigation device tracking system
Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set
ACESSA HEALTH INC.
5200
In Commercial Distribution

  • 00854763006126 ()


  • Electromagnetic surgical navigation device tracking system
Connects the Guidance Handpiece to the Acessa Generator and the Guidance Controller.
HALT MEDICAL, INC
5400
In Commercial Distribution

  • 00854763006096 ()
5400

  • Electromagnetic surgical navigation device tracking system
Disposable handpiece connects to generator
HALT MEDICAL, INC
5300
In Commercial Distribution

  • 00854763006089 ()
5300

  • Electromagnetic surgical navigation device tracking system
Cable connects the pads to the generator
HALT MEDICAL, INC
4300
In Commercial Distribution

  • 00854763006072 ()
4300

  • Electromagnetic surgical navigation device tracking system
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