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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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Penumbra Coil 400 - M4244002C04120

PC400 Cplx Std, 4x12
PENUMBRA, INC.
4002C0412
In Commercial Distribution

  • M4244002C04120 ()
  • 00814548010489 ()


  • Embolization implant kit

Penumbra Coil 400 - M4244002C04100

PC400 Cplx Std, 4x10
PENUMBRA, INC.
4002C0410
In Commercial Distribution

  • M4244002C04100 ()
  • 00814548013374 ()


  • Embolization implant kit

Penumbra Coil 400 - M4244002C04080

PC400 Cplx Std, 4x8
PENUMBRA, INC.
4002C0408
In Commercial Distribution

  • M4244002C04080 ()
  • 00814548010472 ()


  • Embolization implant kit

Penumbra Coil 400 - M4244002C03200

PC400 Cplx Std, 3x20
PENUMBRA, INC.
4002C0320
In Commercial Distribution

  • M4244002C03200 ()
  • 00814548011578 ()


  • Embolization implant kit

Penumbra Coil 400 - M4244002C03150

PC400 Cplx Std, 3x15
PENUMBRA, INC.
4002C0315
In Commercial Distribution

  • M4244002C03150 ()
  • 00814548011561 ()


  • Embolization implant kit

Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System - M4731210VHP0

Model 1210-VHP - OmniPulse Max Holmium Laser System
TRIMEDYNE, INC.
1210-VHP
In Commercial Distribution

  • M4731210VHP0 ()
  • 00860009228801 ()
1210-VHP

  • General/multiple surgical solid-state laser system

ENVI - H965481020

NEEDLE, 21G X 15CM CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
48-102
In Commercial Distribution

  • H965481020 ()
  • H965481021 ()
  • 15051684023764 ()

  • Needle Gauge: 21 Gauge
  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965481000

NVI SHEATH 6F X 20CM
NAVILYST MEDICAL, INC.
48-100
In Commercial Distribution

  • H965481000 ()
  • H965481001 ()
  • 15051684023740 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

BioFlo - H965468100

BioFlo Midline with ENDEXO Technology MST-45 Kit
NAVILYST MEDICAL, INC.
46810
In Commercial Distribution

  • H965468100 ()
  • 15051684025379 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter


  • Peripheral intravenous cannula

BioFlo - H965467100

BioFlo Midline with ENDEXO Technology MST-45 Kit
NAVILYST MEDICAL, INC.
46710
In Commercial Distribution

  • H965467100 ()
  • 15051684025362 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 1.68 Millimeter


  • Peripheral intravenous cannula
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