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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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COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000384197 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer
Navio Computer Cart
Smith & Nephew, Inc.
PFSR110002
In Commercial Distribution

  • 00885556628478 ()
PFSR110002

  • Robotic surgical arm system
COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000102388 ()


  • Portable computer
COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000102371 ()


  • Nerve-locating system
MRI Monitor Remote Tablet
IRADIMED CORP.
3885T
In Commercial Distribution

  • 00856038001201 ()
3885T

  • Portable computer
WIN10 CPU UPGRADE FOR CAPTURE (IN WARRANTY)
Leica Biosystems Richmond, Inc.
23CAPWARW10CPU
Not in Commercial Distribution

  • 00849832013495 ()

  • Device Size Text, specify:


  • Desktop computer
WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)
Leica Biosystems Richmond, Inc.
23GSLWARW10CPU
Not in Commercial Distribution

  • 00849832013488 ()

  • Device Size Text, specify:


  • Desktop computer
Dell 6 BUTTON LASER MOUSE
Leica Biosystems Richmond, Inc.
23MOS0002
Not in Commercial Distribution

  • 00849832013426 ()

  • Device Size Text, specify:


  • Desktop computer
Dell Precision 5820
Leica Biosystems Richmond, Inc.
23CPU1066
Not in Commercial Distribution

  • 00849832013372 ()

  • Device Size Text, specify:


  • Desktop computer
Dell Precision 3620
Leica Biosystems Richmond, Inc.
23CPU1065
Not in Commercial Distribution

  • 00849832013365 ()

  • Device Size Text, specify:


  • Desktop computer
Dell Laser Mouse
Leica Biosystems Richmond, Inc.
23MOS0001
Not in Commercial Distribution

  • 00849832013181 ()

  • Device Size Text, specify:


  • Desktop computer
PC Graphics Card - Nvidia Geforce GT610
Leica Biosystems Richmond, Inc.
23BDG0033
Not in Commercial Distribution

  • 00849832012153 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems Nvidia Quadro 600
Leica Biosystems Richmond, Inc.
23BDG0031
Not in Commercial Distribution

  • 00849832011538 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems HP Z420 Workstation R
Leica Biosystems Richmond, Inc.
23CPUZ420HP01R
Not in Commercial Distribution

  • 00849832011521 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems DELL 7910 CV Ultimate Service PC
Leica Biosystems Richmond, Inc.
23CPU7910ULT_SPARE
Not in Commercial Distribution

  • 00849832010920 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems Ariol Workstation PC for Legacy Hardware
Leica Biosystems Richmond, Inc.
23AUWS
In Commercial Distribution

  • 00849832003878 ()

  • Device Size Text, specify:


  • Desktop computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer
SOMNOSTAR 11 UPGRADE
Carefusion Corporation
29675-001
Not in Commercial Distribution

  • 10846446033298 ()
29675-001

  • Desktop computer
OPTIPLEX XE2 WIN7 64BIT ENGLISH 100_240V (VMAX)
Carefusion Corporation
26751-307
Not in Commercial Distribution

  • 10846446026443 ()
26751-307

  • Desktop computer
Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
In Commercial Distribution

  • B155EM40 ()
  • 04032767832866 ()


  • Portable computer
Optical Mouse
Karl Storz GmbH & Co. KG
40800028
In Commercial Distribution

  • 04048551009864 ()


  • Computer terminal
Chromebook for Arial Web Client Only
Securitas Healthcare LLC
54385
In Commercial Distribution

  • 00840948103025 ()
54385

  • Desktop computer
Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
Arial U Client PC
Securitas Healthcare LLC
56111
In Commercial Distribution

  • 00840948101076 ()


  • Desktop computer
TOWER, CONFIGURED, WIN 10, 64 BIT, ARIAL CLIENT
Securitas Healthcare LLC
0900-696
In Commercial Distribution

  • 00840948100994 ()


  • Desktop computer
Arial Tower, Configured, Arial Client
Securitas Healthcare LLC
0900-652
In Commercial Distribution

  • 00840948100833 ()


  • Desktop computer
Planning Station
Covidien LP
AED00172-30
In Commercial Distribution

  • 10884521545588 ()


  • Portable computer
iLogic inReach;Planning Laptop
Covidien LP
AED00147-20
In Commercial Distribution

  • 10884521200364 ()


  • Portable computer
Planning Station
Covidien LP
AED00170-01
In Commercial Distribution

  • 10884521582835 ()


  • Portable computer
superDimension Planning Station
Covidien LP
ILS-0726-PS
In Commercial Distribution

  • 10884521785861 ()


  • Portable computer
No Description
Drägerwerk AG & Co. KGaA
MS17277
Not in Commercial Distribution

  • 04048675053682 ()


  • Desktop computer
IMAGE1 PILOT
Karl Storz GmbH & Co. KG
TC014
In Commercial Distribution

  • 04048551387337 ()


  • Desktop computer
No Description
Carl Zeiss Meditec AG
Model II
In Commercial Distribution

  • 04049539103512 ()


  • Desktop computer
No Description
Carl Zeiss Meditec AG
Model III
In Commercial Distribution

  • 04049539069214 ()


  • Desktop computer
No Description
Advanced Bionics AG
CI-6126
Not in Commercial Distribution

  • 07630016882944 ()


  • Portable computer
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