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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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Simulus™ - 00613994867094

RING SIM SR 800SR40 SEMI-RIGID
MEDTRONIC, INC.
800SR40
Not in Commercial Distribution

  • 00613994867094 ()

  • Lumen/Inner Diameter: 40.0 Millimeter


  • Mitral annuloplasty ring

NA - 10681490268551

ANNULOPLASTY BAND,POSTERIOR,63MM
MEDTRONIC, INC.
H607M63
Not in Commercial Distribution

  • 10681490268551 ()

  • Lumen/Inner Diameter: 63.0 Millimeter


  • Mitral/tricuspid annuloplasty ring

TRUMPET - 08054187380556

Trumpet REM is a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process.
INVENTIS SRL
TRUMPET REM
In Commercial Distribution

  • 08054187380556 ()
10866

  • Ear canal insertion gain measurement instrument

FORA - 00816042012846

Blood Glucose Plus Blood Pressure Monitoring System
FORA CARE INC.
D40 Pro
In Commercial Distribution

  • 00816042012846 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Home-use/point-of-care glucose analyser IVD, battery-powered

FORA - 00816042012044

Blood Glucose Plus Blood Pressure Monitoring System
FORA CARE INC.
D40g
In Commercial Distribution

  • 00816042012044 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Home-use/point-of-care glucose analyser IVD, battery-powered

MITRACLIP - 08717648195921

STEERABLE GUIDE CATHETER, MITRACLIP US
ABBOTT VASCULAR
SGC0101
Not in Commercial Distribution

  • 08717648195921 ()
SGC0101

  • Mitral valve tissue repair system

MITRACLIP - 08717648195914

CLIP DELIVERY SYSTEM, MITRACLIP US
ABBOTT VASCULAR
CDS0201
Not in Commercial Distribution

  • 08717648195914 ()
CDS0201

  • Mitral valve tissue repair system

Protech Proguard - 08054301890015

Radiation Reducing Glove
EMERSON & CO SRL
RR165
In Commercial Distribution

  • 08054301890756 ()
  • 08054301890015 ()
RR165

  • Radiation shielding glove

CARDINAL HEALTH - 20885380020282

H.pylori Rapid Test
Cardinal Health 200, LLC
B1077-25
Not in Commercial Distribution

  • 50885380020283 ()
  • 20885380020282 ()
  • 10885380020285 ()
B1077-25

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

PRO ADVANTAGE - M220P0800953

PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080095
In Commercial Distribution

  • M220P0800955 ()
  • M220P0800953 ()
P080095

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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