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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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MRIdian A3i Software - 00850036816027

No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution

  • 00850036816027 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging

e-Ortho Shoulder Software - 03661489709067

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
0100011575
In Commercial Distribution

  • 03661489709067 ()


  • Orthopaedic/craniofacial implantation planning software

neuromate - neuroinspire software - 03662724000482

No Description
RENISHAW MAYFIELD
neuroinspire SW Atlas Module
In Commercial Distribution

  • 03662724000482 ()
001.0123

  • Neurological stereotactic surgery system

neuromate neuroinspire software - 03662724000390

No Description
RENISHAW MAYFIELD
neuroinspire planning software
In Commercial Distribution

  • 03662724000390 ()
001.0142

  • Neurological stereotactic surgery system

Holter Analysis Software - M581NEMK1630

Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1620

Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1610

Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1600

Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system

4Sight: Software Package - 00897826002147

No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system

CAD/CAM Software - E27668347040

CEREC SW 5.3 Workstation dig., Secondary
SIRONA Dental Systems GmbH
6834704
In Commercial Distribution

  • E27668347040 ()
6834704

  • CAD/CAM software

CAD/CAM Software - E27668346960

CEREC SW 5.3 Workstation, Secondary
SIRONA Dental Systems GmbH
6834696
In Commercial Distribution

  • E27668346960 ()
6834696

  • CAD/CAM software

CAD/CAM Software - E27668346880

CEREC SW 5.3 license upgrade digital
SIRONA Dental Systems GmbH
6834688
In Commercial Distribution

  • E27668346880 ()
6834688

  • CAD/CAM software

CAD/CAM Software - E27668346700

CEREC SW 5.3 License Key Upgrade
SIRONA Dental Systems GmbH
6834670
In Commercial Distribution

  • E27668346700 ()
6834670

  • CAD/CAM software

CAD/CAM Software - E27668346620

CEREC SW 5.3 Full version dig., Primary
SIRONA Dental Systems GmbH
6834662
In Commercial Distribution

  • E27668346620 ()
6834662

  • CAD/CAM software

CAD/CAM Software - E27668346540

CEREC SW 5.3 Full version, Primary
SIRONA Dental Systems GmbH
6834654
In Commercial Distribution

  • E27668346540 ()
6834654

  • CAD/CAM software

CAD/CAM Software - E27668346470

CEREC SW 5.3 license
SIRONA Dental Systems GmbH
6834647
In Commercial Distribution

  • E27668346470 ()
6834647

  • CAD/CAM software

CAD/CAM Software - E27668346390

CEREC SW 5.3 License Upgrade Club
SIRONA Dental Systems GmbH
6834639
In Commercial Distribution

  • E27668346390 ()
6834639

  • CAD/CAM software

CAD/CAM Software - E27668231110

CEREC SW 5.2 & Pro SW-Upgrade digital
SIRONA Dental Systems GmbH
6823111
In Commercial Distribution

  • E27668231110 ()
6823111

  • CAD/CAM software

CAD/CAM Software - E27668231030

CEREC SW v5.2 licence upgrade
SIRONA Dental Systems GmbH
6823103
In Commercial Distribution

  • E27668231030 ()
6823103

  • CAD/CAM software

CAD/CAM Software - E27668208930

CEREC SW V5.3
SIRONA Dental Systems GmbH
6820893
In Commercial Distribution

  • E27668208930 ()
6820893

  • CAD/CAM software
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