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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0.35 mm x 2 cm VISICOIL
Izi Medical Products, LLC
FP-0010
In Commercial Distribution

  • B887FP00100 ()
FP-0010

  • Radiological image marker, implantable
0.35 mm x 1 cm VISICOIL
Izi Medical Products, LLC
FP-0009
In Commercial Distribution

  • B887FP00090 ()
FP-0009

  • Radiological image marker, implantable
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution

  • 03760305400086 ()
30-0001-01-USA

  • Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution

  • 03760305400079 ()
02-0044

  • Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution

  • 03760305400062 ()
02-0027-19G

  • Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution

  • 03760305400055 ()
02-0031

  • Robotic surgical navigation system
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
QUANTUM SURGICAL
30-0001 v1.0.2
In Commercial Distribution

  • 03760305400031 ()


  • Robotic surgical navigation system
The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution

  • 03760305400024 ()
02-0026

  • Robotic surgical navigation system
Marker Delivery Kit
Covidien LP
SDMDK1000
In Commercial Distribution

  • 20884521809564 ()
  • 10884521809567 ()

  • Length: 125 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 0.038 Inch


  • Bronchoscopic catheter
Patient Sensor Patches
Covidien LP
ILS-1000-SP
In Commercial Distribution

  • 20884521842424 ()
  • 10884521807983 ()


  • Multi-purpose surgical skin adhesive tape
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