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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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FlexForm Annuloplasty Band - B040FBH400

Annuloplasty Band
GENESEE BIOMEDICAL, INC.
FBH-40
In Commercial Distribution

  • B040FBH40 ()
  • B040FBH400 ()


  • Mitral/tricuspid annuloplasty ring

CoaguChek XS PT strips - 04015630946471

No Description
Roche Diagnostics GmbH
7797826160
In Commercial Distribution

  • 04015630946471 ()
7797826160

  • Home-use/point-of-care coagulation analyser IVD, battery-powered

Duran AnCore® - 00721902859816

RING 620RG33 ANLO DURAN ANCORE CHORD 10L
MEDTRONIC, INC.
620RG33
Not in Commercial Distribution

  • 00721902859816 ()

  • Lumen/Inner Diameter: 33.0 Millimeter


  • Mitral/tricuspid annuloplasty ring

Duran AnCore® - 00721902859762

RING 620RG25 ANLO DURAN ANCORE CHORD 10L
MEDTRONIC, INC.
620RG25
Not in Commercial Distribution

  • 00721902859762 ()

  • Lumen/Inner Diameter: 25.0 Millimeter


  • Mitral/tricuspid annuloplasty ring

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

BENCO - 00366975013033

MASK BENCO LVL 3 BLU BX50
BENCO DENTAL SUPPLY CO.
5251-498
In Commercial Distribution

  • 10366975013030 ()
  • 00366975013033 ()
  • 00366975013101 ()
5251-498

  • Surgical/medical face mask, single-use
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