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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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Delivery Analysis TM - M65810573750

Software, Delivery Analysis, Version 1.2
ACCURAY INCORPORATED
1057375
In Commercial Distribution

  • M65810573750 ()
NA

  • Linear accelerator system

Delivery Analysis TM - M65810525910

Software, Delivery Analysis, Version 1.1
ACCURAY INCORPORATED
1052591
In Commercial Distribution

  • M65810525910 ()
NA

  • Linear accelerator system

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

Monarch™ Software Laptop v2.1.5 - B634SW0032760201050

Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software

Monarch™ Software Laptop v2.1.4 - B634SW0032760201040

Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software

Monarch™ Software Laptop v2.1.3 - B634SW0032760201030

Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software

Monarch™ Software Laptop v2.1.2 - B634SW0032760201020

Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software

Monarch™ Software Cart v2.1.5 - B634SW0032750201050

Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032750201050 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.4 - B634SW0032750201040

Monarch™ Software Cart v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032750201040 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.3 - B634SW0032750201030

Monarch™ Software Cart v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032750201030 ()


  • Robotic surgical system application software
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