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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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INTUA™ - 00802526536663

Cardiac Resynchronization Therapy Pacemaker
BOSTON SCIENTIFIC CORPORATION
V272
In Commercial Distribution

  • 00802526536663 ()


  • Cardiac resynchronization therapy implantable pacemaker

AMDS Hybrid Prosthesis ("AMDS") - 00877234001215

55mm Straight Stent (32mm collar)
Artivion, Inc.
K039422
In Commercial Distribution

  • 00877234001215 ()

  • Catheter Length: 565 Millimeter
  • Aortic Stent Proximal Diameter: 36-45mm
  • Aortic Stent Distal Diameter: 36-45mm
  • Aortic Stent Minimum Length:187mm
  • Aortic Stent Maximum Length:215mm
  • Stent Collar Diameter: 32mm
AMDS55

  • Bare-metal aortic stent

AMS 700 CX MS Pump - 00878953003870

AMS 700 Inflatable Penile Prosthesis, Preconnected 1 MS Pump to 2 CX Cylinders, Penoscrotal
BOSTON SCIENTIFIC CORPORATION
72404284
In Commercial Distribution

  • 00878953003870 ()

  • Length: 24 Centimeter
  • Outer Diameter: 12 Millimeter
72404284

  • Inflatable penile prosthesis

Sentimag - 15060391210350

Thin Probe for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Thin Probe
In Commercial Distribution

  • 15060391210350 ()
SMP03T

  • Magnetic metal detector

Sentimag - 15060391210343

Probe checker for Sentimag Gen 3 Probe
ENDOMAGNETICS LTD
Gen 3 Probe Checker
In Commercial Distribution

  • 15060391210343 ()
SMC03

  • Magnetic metal detector

Sentimag - 15060391210336

Footswitch for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Footswitch
In Commercial Distribution

  • 15060391210336 ()
SMA03

  • Magnetic metal detector

Sentimag - 15060391210329

Standard Probe for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Probe
In Commercial Distribution

  • 15060391210329 ()
SMP03

  • Magnetic metal detector

Sentimag - 15060391210312

Sentimag Gen 3 Base Unit
ENDOMAGNETICS LTD
Gen 3
In Commercial Distribution

  • 15060391210312 ()
SMB03

  • Magnetic metal detector

Advin Multi-Drug Screen Test - B115ABCARDA10141

BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10141 ()
  • B115ABCARDA10140 ()
ABCardA-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Advin Multi-Drug Screen Test - B115ABCARD10141

BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10141 ()
  • B115ABCARD10140 ()
ABCard-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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