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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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
MRI Monitor Remote Tablet
IRADIMED CORP.
3885T
In Commercial Distribution

  • 00856038001201 ()
3885T

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

  • 07630016882944 ()


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

  • 07630016882623 ()


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

  • 07630016864650 ()


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

  • 07630016862809 ()


  • Portable computer
Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
em4
In Commercial Distribution

  • B155EM40 ()


  • Portable computer
BiOM T2 Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
2001219
In Commercial Distribution

  • B15520012190 ()


  • Portable computer
SYNERGY VISION TABLET
ARTHREX, INC.
AR-3200-1016
In Commercial Distribution

  • 00888867435797 ()
AR-3200-1016

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

  • 10884521785861 ()


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

  • B155EM40 ()
  • 04032767832866 ()


  • 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
No Description
Thoratec Corporation
20010-2810-000
In Commercial Distribution

  • 00813024013372 ()
20010-2810-000

  • Portable computer
No Description
Thoratec Corporation
105620
In Commercial Distribution

  • 00813024011804 ()
105620

  • Portable computer
No Description
Thoratec Corporation
105410
In Commercial Distribution

  • 00813024011781 ()
105410

  • Portable computer
No Description
Thoratec Corporation
105400
In Commercial Distribution

  • 00813024011767 ()
105400

  • Portable computer
ERC 2P Laptop Assembly US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_US
In Commercial Distribution

  • 00887517969132 ()
ERC2P-LAPTOP_P_US

  • Portable computer
ERC 2P Laptop Assembly EU
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_EU
In Commercial Distribution

  • 00887517969118 ()

  • Tools/Instruments
ERC2P-LAPTOP_P_EU

  • Portable computer
ERC 2P Laptop Assembly UK
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_UK
In Commercial Distribution

  • 00887517969125 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_UK

  • Portable computer
ERC 2P Laptop Assembly AR
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_AR
In Commercial Distribution

  • 00887517969101 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_AR

  • Portable computer
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027
In Commercial Distribution

  • 00885556757451 ()
ROB10027

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027S
In Commercial Distribution

  • 00885556780879 ()
ROB10027S

  • Portable computer
Tablet for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
WA021
Not in Commercial Distribution

  • 00627908080097 ()


  • Evoked-potential audiometer
Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
11010
Not in Commercial Distribution

  • 00627908080042 ()


  • Evoked-potential audiometer
Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD
Cardinal Health 200, LLC
CH6870
In Commercial Distribution

  • 50885380096745 ()
  • 20885380096744 ()
  • 10885380096747 ()
CH6870

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical
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