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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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EXACTECHGPS - 10885862266675

TRAVEL CASE
Exactech, Inc.
I00022
In Commercial Distribution

  • 10885862266675 ()

  • V2
I00022

  • Robotic surgical navigation system

EXACTECHGPS - 10885862266668

POWER SUPPLY
Exactech, Inc.
I00021
In Commercial Distribution

  • 10885862266668 ()

  • V2
I00021

  • Robotic surgical navigation system

EXACTECHGPS - 10885862266651

IMPLANT KIT
Exactech, Inc.
A10012
In Commercial Distribution

  • 10885862266651 ()

  • V2
A10012

  • Robotic surgical navigation system

EXACTECHGPS - 10885862518767

SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system

EXACTECHGPS - 10885862518927

MOUNTING ARM
Exactech, Inc.
J00020
In Commercial Distribution

  • 10885862518927 ()

  • UPPER
J00020

  • Robotic surgical navigation system

EXACTECHGPS - 10885862625601

Mounting Arm – Upper Part 4 positions
Exactech, Inc.
J00065
In Commercial Distribution

  • 10885862625601 ()

  • V2
J00065

  • Robotic surgical navigation system

EXACTECHGPS - 10885862574091

STATION2+
Exactech, Inc.
I00025
In Commercial Distribution

  • 10885862574091 ()

  • V2
I00025

  • Robotic surgical navigation system

EXACTECHGPS - 10885862553331

MOBILE CART
Exactech, Inc.
J00120
In Commercial Distribution

  • 10885862553331 ()

  • V2
J00120

  • Robotic surgical navigation system

Genesis MNS with Model-S - M58800101100030

"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system

Genesis (RMNS) - M58800101100010

Genesis RMNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
Stereotaxis, Inc.
1.1
In Commercial Distribution

  • M58800101100010 ()
001-011000-1

  • Robotic surgical navigation system
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