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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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Portrait CSS01 - 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software

Portrait CVA01 - 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only

Radixact™ Treatment Delivery System - M65810602530

Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system

Zvu - 00816734022429

Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system

CyberLAB - B433CL0

Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software

360CAS - B432360CAS3100

360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software

GoCheck Kids - B430GCKNOK44290L

Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera

VULCAN - 03596010612793

PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation system

LF - 10746190004813

OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary

LF - 10746190004806

OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary
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