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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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Aurora Xi - 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020440171

Software version for AMICUS Separator life extension device
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 00810020440171 ()


  • Apheresis system

Stellaris - 00757770520251

Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
In Commercial Distribution

  • 00757770520251 ()
BL14304

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770520190

Stellaris Vision Enhancement System with Version 4+ Software
Bausch & Lomb Incorporated
BL11114
In Commercial Distribution

  • 00757770520190 ()
BL11114

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770519996

Stellairs PC Combined System with Version 4+ Software
Bausch & Lomb Incorporated
BL14334
In Commercial Distribution

  • 00757770519996 ()
BL14334

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770519897

Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system

VP2000 - 00884999048478

VP 2000 System Software v2.1 with Protocols USB
ABBOTT MOLECULAR INC.
02J11-057
In Commercial Distribution

  • 00884999048478 ()
02J11-057

  • Tissue processor IVD, automated/semi-automated

Norav 1200 Series PC-ECG - 07290110255008

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Driver for P-MP200 Thermal Printer The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW P-MP200
In Commercial Distribution

  • 07290110255008 ()
HASP-SW-K-P1-01

  • Thermal printer

Norav 1200 Series PC-ECG - 07290110252649

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - L1 = Late Potential Analysis Module The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW L1
In Commercial Distribution

  • 07290110252649 ()
HASP-SW-K-L1-01

  • Cardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG - 07290110252670

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

  • 07290110252670 ()
HASP-SW-K-NER1-01

  • Electrocardiographic long-term ambulatory recording analyser
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