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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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No Description
Brainlab AG
3.1
Not in Commercial Distribution

  • 04056481000462 ()
22217-01A

  • Robotic surgical navigation system
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000271 ()
25134-02

  • Robotic surgical navigation system
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000257 ()
26250-02A

  • Robotic surgical navigation system
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000240 ()
26227-02

  • Robotic surgical navigation system
No Description
Brainlab AG
1
Not in Commercial Distribution

  • 04056481000233 ()
22240-06

  • Robotic surgical navigation system
ORTHOPILOT CAP SINGLE-USE MARKERS
Aesculap AG
FS618SU
In Commercial Distribution

  • 04046964105296 ()
  • 04046964105289 ()
FS618SU

  • Robotic surgical navigation system
TRAVEL CASE
Exactech, Inc.
I00022
In Commercial Distribution

  • 10885862266675 ()

  • V2
I00022

  • Robotic surgical navigation system
POWER SUPPLY
Exactech, Inc.
I00021
In Commercial Distribution

  • 10885862266668 ()

  • V2
I00021

  • Robotic surgical navigation system
IMPLANT KIT
Exactech, Inc.
A10012
In Commercial Distribution

  • 10885862266651 ()

  • V2
A10012

  • Robotic surgical navigation system
STATION
Exactech, Inc.
I00020
In Commercial Distribution

  • 10885862252821 ()

  • V2
I00020

  • Robotic surgical navigation system
IMPLANT KIT
Exactech, Inc.
A10007
In Commercial Distribution

  • 10885862144294 ()

  • V1
A10007

  • Robotic surgical navigation system
TRACKER
Exactech, Inc.
A10005
In Commercial Distribution

  • 10885862144287 ()

  • T
A10005

  • Robotic surgical navigation system
TRACKER
Exactech, Inc.
A10006
In Commercial Distribution

  • 10885862144270 ()

  • G
A10006

  • Robotic surgical navigation system
TRACKER
Exactech, Inc.
A10004
In Commercial Distribution

  • 10885862144263 ()

  • F
A10004

  • Robotic surgical navigation system
PROBE
Exactech, Inc.
A10003
In Commercial Distribution

  • 10885862144256 ()
A10003

  • Robotic surgical navigation system
POWER CABLE
Exactech, Inc.
K00001
In Commercial Distribution

  • 10885862144225 ()
K00001

  • Robotic surgical navigation system
MOUNTING ARM CLAMP
Exactech, Inc.
J00011
In Commercial Distribution

  • 10885862144218 ()
J00011

  • Robotic surgical navigation system
MOUNTING ARM
Exactech, Inc.
J00010
In Commercial Distribution

  • 10885862144195 ()

  • LOWER
J00010

  • 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
In Commercial Distribution

  • 03760305400086 ()
30-0001-01-USA

  • 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 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
CREO DLX Rigid Screwdriver Outer Sleeve, GI1
GLOBUS MEDICAL, INC.
6156.1405
In Commercial Distribution

  • 00889095815566 ()


  • Robotic surgical navigation system
CREO DLX Rigid Screwdriver Shaft, GI1
GLOBUS MEDICAL, INC.
6156.1400
In Commercial Distribution

  • 00889095815559 ()


  • Robotic surgical navigation system
CREO DLX Rigid Screwdriver Outer Sleeve, GPS
GLOBUS MEDICAL, INC.
6156.1095
In Commercial Distribution

  • 00889095815542 ()


  • Robotic surgical navigation system
CREO DLX Rigid Screwdriver Shaft, GPS
GLOBUS MEDICAL, INC.
6156.1090
In Commercial Distribution

  • 00889095815535 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Outer Sleeve, GI1
GLOBUS MEDICAL, INC.
6200.1405
In Commercial Distribution

  • 00889095782486 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Shaft, GI1
GLOBUS MEDICAL, INC.
6200.1400
In Commercial Distribution

  • 00889095782479 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Outer Sleeve, GPS
GLOBUS MEDICAL, INC.
6200.1095
In Commercial Distribution

  • 00889095782462 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Shaft, GPS
GLOBUS MEDICAL, INC.
6200.1090
In Commercial Distribution

  • 00889095782455 ()


  • Robotic surgical navigation system
Passive Tube Array, 15mm, GPS
GLOBUS MEDICAL, INC.
6143.2542
In Commercial Distribution

  • 00889095740912 ()


  • Robotic surgical navigation system
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