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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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TLIF Trial 30 x 10 x 10 x 0 deg
Tyber Medical, LLC
002-T3010002
In Commercial Distribution

  • M695002T30100020 ()
002-T3010002

  • Metal-polymer composite spinal interbody fusion cage
PFFG3-32 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-32
In Commercial Distribution

  • 10856449006205 ()
  • 00856449006208 ()
  • 20856449006202 ()

  • Catheter Gauge: 32 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
05-1001-653, +90 Inserter With Pre-loaded Vent Tube
PRECEPTIS MEDICAL, INC
05-1001-653
In Commercial Distribution

  • 50853386007072 ()
  • 00853386007077 ()
05-1001-653

  • Tympanostomy tube
05-1001-652, -90 Inserter With Pre-loaded Vent Tube
PRECEPTIS MEDICAL, INC
05-1001-652
In Commercial Distribution

  • 50853386007065 ()
  • 00853386007060 ()
05-1001-652

  • Tympanostomy tube
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC
9750TFX26
In Commercial Distribution

  • 00690103201338 ()

  • Outer Diameter, 26 MM
9750TFX26A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Basic crimper
  • Catheter/overtube balloon inflator, single-use
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC
9750TFX23
In Commercial Distribution

  • 00690103201321 ()

  • Outer Diameter, 23 MM
9750TFX23A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Basic crimper
  • Catheter/overtube balloon inflator, single-use
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC
9750TFX20
In Commercial Distribution

  • 00690103201314 ()

  • Outer Diameter, 20 MM
9750TFX20A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Basic crimper
  • Catheter/overtube balloon inflator, single-use
10 BIFURCATED EXTENSION SET
Cardinal Health 200, LLC
10EY
In Commercial Distribution

  • 50192253006597 ()
  • 10192253006599 ()

  • Length: 10 Inch
10EY

  • Gastrostomy tube
10 IN EXTENSION SET
Cardinal Health 200, LLC
10ES
In Commercial Distribution

  • 50192253006580 ()
  • 10192253006582 ()

  • Length: 10 Inch
10ES

  • Gastrostomy tube
LATERAL INTERBODY, 26x60x18mm, 10°
OMNIA MEDICAL, LLC
13-0L-266018-10
In Commercial Distribution

  • 00843511107857 ()

  • Width: 26 Millimeter
  • Length: 60 Millimeter
  • Height: 18 Millimeter
  • Angle: 10 degree
13-0L-266018-10

  • Polymeric spinal interbody fusion cage
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