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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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TRUEmanager - 00021292008666

TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software

Monarch Software Laptop v2.2.1 - B634SW0121940202000

Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121940202000 ()


  • CT system application software

Monarch Software Cart v2.2.1 - B634SW0121930202000

Monarch Software Cart v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121930202000 ()


  • Robotic surgical system application software

Monarch Software Tower v2.2.1 - B634SW0121920202000

Monarch Software Tower v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121920202000 ()


  • Robotic surgical system application software

Monarch Software Laptop v2.1.6 - B634SW0121900201060

Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121900201060 ()


  • CT system application software

Monarch Software Cart v2.1.6 - B634SW0121890201060

Monarch Software Cart v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121890201060 ()


  • Robotic surgical system application software

Monarch Software Tower v2.1.6 - B634SW0121880201060

Monarch Software Tower v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121880201060 ()


  • Robotic surgical system application software

SpecialsLab - 00840682123587

SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Mac-Lab - 00840682123556

SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

KBA3D - 03701313007935

Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software

DYONICS POWER - 03596010622716

DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered

INTEGRATION BROKER - 03596010589637

SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software

N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

Keypoint - 00382830050302

Review Software (Single User)
NATUS MANUFACTURING LIMITED
9033S0628
In Commercial Distribution

  • 00382830050302 ()
9033S0628

  • Electromyograph

FreeStyle Libre - 00357599000479

FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software

Natus - 00382830019231

NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph

Embla - 00382830048484

RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software

Xltek - 00382830043458

RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software

Natus - 00382830039475

SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph

Natus - 00382830038034

Synergy Application Software v20.0
NATUS NEUROLOGY INCORPORATED
482-645500
In Commercial Distribution

  • 00382830038034 ()


  • Electromyograph

Natus - 00382830038003

Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph

AESCULAP - 04046963181901

ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

AEOS - 04046955206803

SOFTWARE MODULE DIR 800
Aesculap AG
PV023
In Commercial Distribution

  • 04046955206803 ()
PV023

  • Surgical microscope fluorescent angiography system

AESCULAP - 04046955206797

SOFTWARE MODULE DUV 400
Aesculap AG
PV022
In Commercial Distribution

  • 04046955206797 ()
PV022

  • Neurosurgical microscope

n.a. - 04048551392270

SCB control NEO Software
Karl Storz GmbH & Co. KG
20090001-47
In Commercial Distribution

  • 04048551392270 ()


  • Operating room audiovisual data/device management system application software

Alaris - 10885403516054

Alaris EtCO2 V12.3 Software
CAREFUSION 303, INC.
8300
In Commercial Distribution

  • 10885403516054 ()


  • Carbon dioxide monitor

AESCULAP - 04046963895853

ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software

AESCULAP - 04046963977979

ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

KARL STORZ AIDA - 04048551012888

AIDA 2.0 Office Software
Karl Storz GmbH & Co. KG
20040013-V01
In Commercial Distribution

  • 04048551012888 ()


  • Operating room audiovisual data/device management system application software

CS OMS Imaging Software - 60192156851666

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software - 60192156851659

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851659 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software

CS Orthodontic Imaging Software - 60192156851642

CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software

ManoView - 07290101369578

ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system

PillCam - 07290101366751

PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software

Manoscan - 07290101366102

CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365945

v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365938

CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365785

AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system

Reflux - 07290110360436

Reflux software v6.1 upgrade
Given Imaging, Inc.
FGS-0657
In Commercial Distribution

  • 07290110360436 ()


  • Gastrointestinal telemetric monitoring system

ARROW - 00801902084859

AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219214

SiteRite 9 Sherlock Software
Bard Access Systems, Inc.
Sherlockv3.3.0
In Commercial Distribution

  • 00801741219214 ()
Sherlockv3.3.0

  • General-purpose ultrasound imaging system
  • Central venous catheter navigation system, electrocardiographic/magnetic

Ascom - 17350088671396

TELLIGENCE BRIDGE SOFTWARE V7.0
Ascom (Sweden) AB
NGTELL70-S
In Commercial Distribution

  • 17350088671396 ()


  • Nurse call system

Ascom - 17350088671372

TELLIGENCE BRIDGE SOFTWARE V6.4
Ascom (Sweden) AB
NGTELL64-S
In Commercial Distribution

  • 17350088671372 ()


  • Nurse call system

Ascom - 17350088671297

TELLIGENCE BRIDGE SOFTWARE V6.3
Ascom (Sweden) AB
NGTELL63-S
In Commercial Distribution

  • 17350088671297 ()


  • Nurse call system

Ascom - 17350088671266

TELLIGENCE BRIDGE SOFTWARE V5.2
Ascom (Sweden) AB
NGTELL52-S
In Commercial Distribution

  • 17350088671266 ()


  • Nurse call system
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