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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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AESCULAP - 04046963895860

ORTHOPILOT SOFTWARE ACL SGL.+DBL.BUNDLE
Aesculap AG
FS227
Not in Commercial Distribution

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system application software

AESCULAP - 04046963895853

ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963977979

ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software

AESCULAP - 04038653423316

ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software

Op.n ChoiceSpine App - 03701311501497

No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software

Op.n Perla TL Nav Software - 03701311501480

No Description
ECENTIAL ROBOTICS
L60017
In Commercial Distribution

  • 03701311501480 ()


  • Robotic surgical navigation system application software

3DSRW Software - 03701311500445

No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software

Navigant - M588020004500370

The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS.
Stereotaxis, Inc.
5.1.0
In Commercial Distribution

  • M588020004500370 ()
020-004500-37

  • Robotic surgical navigation system application software
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