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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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Venue Fit - 00198953001103

Venue Fit R6 Final Assembly
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001103 ()


  • General-purpose ultrasound imaging system

Venue Go - 00198953001097

Venue Go R6 Final Assembly
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001097 ()


  • General-purpose ultrasound imaging system

Venue - 00198953001073

Venue R6 final Assembly
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001073 ()


  • General-purpose ultrasound imaging system

Norav 1200 Series PC-ECG - 07290110252663

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - M1 = Continuous Resting-ECG Monitoring The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW M1
In Commercial Distribution

  • 07290110252663 ()
HASP-SW-K-M1-01

  • Patient monitoring system module, electrocardiographic, long-term recording

Norav 1200 Series PC-ECG - 07290110252625

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I1
In Commercial Distribution

  • 07290110252625 ()
HASP-SW-K-I1-01

  • Cardiovascular risk evaluation interpretive software

Vinehealth Cancer Companion - 05070000764115

No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764115 ()


  • Medication reminder application software
  • Clinical management support software

Roentgen Files - 00850631008087

Roentgen Files 4.1.0
Brit Systems, LLC
4.1.0
In Commercial Distribution

  • 00850631008087 ()


  • Radiological PACS software
  • Radiology information system application software

Roentgen Files - 00850631008506

Roentgen Files 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008506 ()


  • Radiological PACS software
  • Radiology information system application software

Scenium - 04056869147925

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298565
In Commercial Distribution

  • 04056869147925 ()


  • PET system application software
  • SPECT system application software

syngo.MI Reading - 04056869147901

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298563
In Commercial Distribution

  • 04056869147901 ()


  • SPECT system application software
  • PET system application software
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