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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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None - 00886874111086

HARMONIC ACE
INTUITIVE SURGICAL, INC.
400272
In Commercial Distribution

  • 00886874111086 ()
  • 10886874111083 ()

  • Outer Diameter: 5 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

None - 00886874111048

TIP COVER ACCESSORY
INTUITIVE SURGICAL, INC.
400180
In Commercial Distribution

  • 10886874111045 ()
  • 00886874111048 ()
  • 30886874111049 ()

  • Outer Diameter: 8 Millimeter


  • Electrosurgical system monitor/shield

daVinci X - 00886874115404

PATIENT SIDE CART, 4-ARM
INTUITIVE SURGICAL, INC.
380620
In Commercial Distribution

  • 00886874115404 ()


  • Robotic surgical arm system

daVinci Xi - 00886874110720

PATIENT SIDE CART, 4-ARM
INTUITIVE SURGICAL, INC.
380652
In Commercial Distribution

  • 00886874110720 ()


  • Robotic surgical arm system

AptiVue™ - 05415067030108

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
1014661
In Commercial Distribution

  • 05415067030108 ()
1014661

  • Cardiac catheterization laboratory computer
  • Coronary optical coherence tomography system

Remote Network Station - 00851725007283

No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490
In Commercial Distribution

  • 00851725007283 ()
RNS-6804-7490

  • Centralized patient monitor

Remote Network Station - 00851725007221

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480
In Commercial Distribution

  • 00851725007221 ()
RNS-6804-7480

  • Centralized patient monitor

Remote Network Station - 00851725007207

No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor

Remote Network Station - 00851725007177

No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor

ATLAS Workstation - 00850011306949

The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system
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