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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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NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

E-LINK Upper Limb Exerciser - 05060481690010

"The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer."
BIOMETRICS LIMITED
E4000
In Commercial Distribution

  • 05060481690010 ()


  • Electronic torsional hand exerciser

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

INTEGRATION BROKER - 03596010589637

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

  • 03596010589637 ()
72201079

  • 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 - 03596010588388

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

  • 03596010588388 ()
72201082

  • 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
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