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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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OMNIBotics - 00841690194019

Software unitary component (common to hip and knee)
Omni Life Science, Inc.
TOOL 14-020
In Commercial Distribution

  • 00841690194019 ()
TOOL 14-020

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194484

Disk Image for CF53SS
Omni Life Science, Inc.
NS-27012
In Commercial Distribution

  • 00841690194484 ()
NS-27012

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194453

OMNIBotics Application System Rev 2.3.0
Omni Life Science, Inc.
NS-27015
In Commercial Distribution

  • 00841690194453 ()
NS-27015

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194439

ART Knee Software Rev 2.6.0
Omni Life Science, Inc.
NS-27017
In Commercial Distribution

  • 00841690194439 ()
NS-27017

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194392

Software Package, ART Knee 2.7
Omni Life Science, Inc.
NS-27114
In Commercial Distribution

  • 00841690194392 ()
NS-27114

  • Robotic surgical navigation system application software

ROSA® KNEE SOFTWARE UPGRADE - 00889024511347

No Description
Orthosoft Inc
20-8020-140-01
In Commercial Distribution

  • 00889024511347 ()
20-8020-140-01

  • Robotic surgical navigation system application software

ROSA® KNEE SOFTWARE - 00889024511330

No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution

  • 00889024511330 ()
20-8020-130-01

  • Robotic surgical navigation system application software

ROSA® Registration Pointer - 00889024505230

No Description
Orthosoft Inc
20-8020-013-00
In Commercial Distribution

  • 00889024505230 ()
20-8020-013-00

  • Robotic surgical navigation system application software

ROSA Partial Knee Software V1.0 - 00889024594036

No Description
Orthosoft Inc
20-8020-150-01
In Commercial Distribution

  • 00889024594036 ()


  • Robotic surgical navigation system application software

INTEGRATION BROKER - 03596010588388

INTEGRATION BROKER ANNUAL SUPPORT DICO
Smith & Nephew, Inc.
72201082
In Commercial Distribution

  • 03596010588388 ()
72201082

  • Robotic surgical navigation system application software

N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

INTEGRATION BROKER - 03596010589637

SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • 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

Navigant - M588020004500260

The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe 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.
5.0.2
In Commercial Distribution

  • M588020004500260 ()
020-004500-26

  • Robotic surgical navigation system application software

Navigant - M588020004500220

The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe 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.
4.6.5
In Commercial Distribution

  • M588020004500220 ()
020-004500-22

  • Robotic surgical navigation system application software

Navigant - M588020004500210

The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe 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.
4.6.4
In Commercial Distribution

  • M588020004500210 ()
020-004500-21

  • 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 - 04046963181901

ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software

AESCULAP - 04046963372446

ORTHOPILOT SOFTWARE THA CUP ONLY
Aesculap AG
FS219
Not in Commercial Distribution

  • 04046963372446 ()
FS219

  • 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 - 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 - 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

NA - 07613154481118

FLUOROSCOPY SOFTWARE 2.3 CD-SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80037
In Commercial Distribution

  • 07613154481118 ()
81-80037

  • Robotic surgical navigation system application software

360CAS - B432360CASSET00290

360 CAS Accessories Set Nav Tower [100-115V]
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0029
In Commercial Distribution

  • B432360CASSET00290 ()


  • Robotic surgical navigation system application software

360CAS - B432360CASSET00280

360 CAS Laptop Camera Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0028
In Commercial Distribution

  • B432360CASSET00280 ()


  • Robotic surgical navigation system application software
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