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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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Cranial Drill with Stop, Ø2.40mm
GLOBUS MEDICAL, INC.
6143.1834S
In Commercial Distribution

  • 00193982302238 ()


  • Robotic surgical arm system
Surveillance Marker Holder
GLOBUS MEDICAL, INC.
6143.1934
In Commercial Distribution

  • 00193982192679 ()


  • Robotic surgical arm system
Cranial Dynamic Reference Base
GLOBUS MEDICAL, INC.
6143.1932
In Commercial Distribution

  • 00193982192655 ()


  • Robotic surgical arm system
Cranial Articulating Arm
GLOBUS MEDICAL, INC.
6143.1931
In Commercial Distribution

  • 00193982192648 ()


  • Robotic surgical arm system
CRW Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1923
In Commercial Distribution

  • 00193982192617 ()


  • Robotic surgical arm system
Leksell Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1921
In Commercial Distribution

  • 00193982192594 ()


  • Robotic surgical arm system
End Effector Guide Tube, 10.0mm
GLOBUS MEDICAL, INC.
6143.1780
In Commercial Distribution

  • 00193982192570 ()


  • Robotic surgical arm system
End Effector Guide Tube, 6.35mm
GLOBUS MEDICAL, INC.
6143.1743
In Commercial Distribution

  • 00193982192563 ()


  • Robotic surgical arm system
End Effector Guide Tube, 2.4mm
GLOBUS MEDICAL, INC.
6143.1704
In Commercial Distribution

  • 00193982192549 ()


  • Robotic surgical arm system
End Effector Guide Tube, 1.8mm
GLOBUS MEDICAL, INC.
6143.1698
In Commercial Distribution

  • 00193982192518 ()


  • Robotic surgical arm system
2.5mm Hex Driver
GLOBUS MEDICAL, INC.
6143.1827
In Commercial Distribution

  • 00193982192365 ()


  • Robotic surgical arm system
Cranial Drill Stop
GLOBUS MEDICAL, INC.
6143.1826
In Commercial Distribution

  • 00193982192358 ()


  • Robotic surgical arm system
Patient Stabilization Stand
GLOBUS MEDICAL, INC.
6143.2505
In Commercial Distribution

  • 00193982185220 ()


  • Robotic surgical arm system
Trajectory Probe, GPS
GLOBUS MEDICAL, INC.
6143.1938
In Commercial Distribution

  • 00193982192686 ()


  • Robotic surgical arm system
Electrode Drive Clamp
GLOBUS MEDICAL, INC.
6143.1933
In Commercial Distribution

  • 00193982192662 ()


  • Robotic surgical arm system
Intraoperative CT Registration Clamp
GLOBUS MEDICAL, INC.
6143.1930
In Commercial Distribution

  • 00193982192631 ()


  • Robotic surgical arm system
3-Pin Fixation Adapter
GLOBUS MEDICAL, INC.
6143.1925
In Commercial Distribution

  • 00193982192624 ()


  • Robotic surgical arm system
CRW Frame Base Adapter
GLOBUS MEDICAL, INC.
6143.1922
In Commercial Distribution

  • 00193982192600 ()


  • Robotic surgical arm system
Leksell Frame Base Adapter
GLOBUS MEDICAL, INC.
6143.1920
In Commercial Distribution

  • 00193982192587 ()


  • Robotic surgical arm system
End Effector Guide Tube, 3.2mm
GLOBUS MEDICAL, INC.
6143.1712
In Commercial Distribution

  • 00193982192556 ()


  • Robotic surgical arm system
End Effector Guide Tube, 2.3mm
GLOBUS MEDICAL, INC.
6143.1703
In Commercial Distribution

  • 00193982192532 ()


  • Robotic surgical arm system
Interchangeable Guide End Effector
GLOBUS MEDICAL, INC.
6143.2504
In Commercial Distribution

  • 00193982143473 ()


  • Robotic surgical arm system
No Description
Orthosoft Inc
20-8020-050-01
In Commercial Distribution

  • 00889024511354 ()
20-8020-050-01

  • Robotic surgical arm system
No Description
Orthosoft Inc
20-8020-120-01
In Commercial Distribution

  • 00889024511323 ()
20-8020-120-01

  • Robotic surgical arm system
Platform
Orthosoft Inc
20-8020-110-01
In Commercial Distribution

  • 00889024511170 ()
20-8020-110-01

  • Robotic surgical arm system
No Description
Orthosoft Inc
20-8020-100-01
In Commercial Distribution

  • 00889024511026 ()
20-8020-100-01

  • Robotic surgical arm system
Window Field Generator, Connection Cable, Mounting System
AURIS HEALTH, INC.
MON-000709
In Commercial Distribution

  • B634MON0007091 ()
  • B634MON0007090 ()
MON-000709

  • Robotic surgical arm system
The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. Monarch Bronchscope 2.0/Monarch Platform (P2)
AURIS HEALTH, INC.
MON-000006
In Commercial Distribution

  • B634MON0000060 ()


  • Robotic surgical arm system
The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005R
In Commercial Distribution

  • B634MON000005R0 ()
MON000005R

  • Robotic surgical arm system
Monarch Endoscopy Platform (P1) System, Refurbished
AURIS HEALTH, INC.
MON-000005-01R
In Commercial Distribution

  • B634MON00000501R0 ()


  • Robotic surgical arm system
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