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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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Needle Guide - 03760305400062

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

Navigation probe - 03760305400055

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

EPIONE - 03760305400031

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

Patient Reference - 03760305400024

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

AESCULAP - 04046964105296

ORTHOPILOT CAP SINGLE-USE MARKERS
Aesculap AG
FS618SU
In Commercial Distribution

  • 04046964105296 ()
  • 04046964105289 ()
FS618SU

  • Robotic surgical navigation system

EXACTECHGPS - 10885862252821

STATION
Exactech, Inc.
I00020
In Commercial Distribution

  • 10885862252821 ()

  • V2
I00020

  • Robotic surgical navigation system

EXACTECHGPS - 10885862632715

Station V3 Disposable Kit
Exactech, Inc.
A10032
In Commercial Distribution

  • 10885862632715 ()
A10032

  • Robotic surgical navigation system

EXACTECHGPS - 10885862628961

Station V3 Carrying Case
Exactech, Inc.
I00032
In Commercial Distribution

  • 10885862628961 ()
I00032

  • Robotic surgical navigation system

EXACTECHGPS - 10885862628954

Station V3 Power Supply
Exactech, Inc.
I00031
In Commercial Distribution

  • 10885862628954 ()
I00031

  • Robotic surgical navigation system

EXACTECHGPS - 10885862628947

Station V3
Exactech, Inc.
I00030
In Commercial Distribution

  • 10885862628947 ()
I00030

  • Robotic surgical navigation system
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