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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3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF0303
In Commercial Distribution

  • B887GF03033 ()
  • B887GF0302 ()
GF0303

  • Radiological image marker, implantable
3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF0303
In Commercial Distribution

  • B887GF03030 ()
GF0303

  • Radiological image marker, implantable
0.8mm x 3mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF0302
In Commercial Distribution

  • B887GF03020 ()
GF0302

  • Radiological image marker, implantable
The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area.
CEFLA SOCIETA' COOPERATIVA
NewTom 7G
In Commercial Distribution

  • 08033837932994 ()
70V10000

  • Full-body CT system
X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
CEFLA SOCIETA' COOPERATIVA
NewTom 5G XL
In Commercial Distribution

  • 08033837931379 ()
P70720008

  • Limited-view-field CT system
Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
670 DR
In Commercial Distribution

  • 00840682124393 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
GE MEDICAL SYSTEMS, INC.
IQ
In Commercial Distribution

  • 00840682103107 ()


  • Full-body CT system
  • PET system
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