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 Class Implantable

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e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850063034203 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
E-Scribe ECG Data Management Workstation - Enterprise system, floating; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323115 ()
ESWKST-DEX-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Department system, node- locked; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323153 ()
ESWKST-AEX-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, node- locked; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323139 ()
ESWKST-CEX-BXXXX

  • Patient health record information system application software
Surveyor Central Repeater Standalone - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094308778 ()
SCREP-CEB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Node - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094285420 ()
SCREP-AEB-XXXXX

  • Centralized patient monitor
E-Scribe ECG Data Management Workstation - Enterprise system, node-locked; Italian system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265071 ()
ESWKST-CEB-BXXXX

  • Patient health record information system application software
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