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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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Barrier - H816BB0312H1

3 x 12 instrument / equipment drape, chair sox
CERTOL INTERNATIONAL, LLC
BB-0312H
In Commercial Distribution

  • H816BB0312H2 ()
  • H816BB0312H1 ()
  • H816BB0312H0 ()
BB-0312H-1

  • Instrument/equipment drape, single-use, non-sterile

VenaCure EVLT - H787EVLTPVAKUS0

VenaCure 400 Micron Perforator and Accessory Vein Ablation Kit
ANGIODYNAMICS, INC.
EVLTPVAKUS
In Commercial Distribution

  • H787EVLTPVAKUS0 ()
  • H787EVLTPVAKUS5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLTPVAK0

VenaCure 400 Micron Fiber Procedure Kit
ANGIODYNAMICS, INC.
EVLT/PVAK
In Commercial Distribution

  • H787EVLTPVAK0 ()
  • H787EVLTPVAK5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT80OPS0

VenaCure 80cm Procedure Kit w/ Spotlight OPS Sheath
ANGIODYNAMICS, INC.
EVLT/80-OPS
In Commercial Distribution

  • H787EVLT80OPS0 ()
  • H787EVLT80OPS5 ()

  • Catheter Gauge: 4 French
  • Length: 80 Centimeter
  • Outer Diameter: 1.2 Millimeter
  • Needle Gauge: 19 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT55OPS0

VenaCure 55cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
ANGIODYNAMICS, INC.
EVLT/55-OPS
In Commercial Distribution

  • H787EVLT55OPS0 ()
  • H787EVLT55OPS5 ()

  • Needle Gauge: 19 Gauge
  • Outer Diameter: 1.2 Millimeter
  • Length: 55 Centimeter
  • Catheter Gauge: 4 French


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT25OPS0

VenaCure 25cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
ANGIODYNAMICS, INC.
EVLT/25-OPS
In Commercial Distribution

  • H787EVLT25OPS0 ()
  • H787EVLT25OPS5 ()

  • Needle Gauge: 19 Gauge
  • Length: 25 Centimeter
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.2 Millimeter


  • Varicose vein lasing procedure kit

ENVI - H965355200

NEEDLE 18G X 15 CHIBA STYLET ECHO TIP GUIDEWIRE, 0.035 X 150CM
NAVILYST MEDICAL, INC.
35-520
In Commercial Distribution

  • H965355200 ()
  • H965355201 ()
  • 15051684023733 ()

  • Lumen/Inner Diameter: 0.95 Millimeter
  • Needle Gauge: 18 Gauge
  • Length: 15 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355190

NEEDLE 18G X 15 CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
35-519
In Commercial Distribution

  • H965355190 ()
  • H965355191 ()
  • 15051684023726 ()

  • Needle Gauge: 18 Gauge
  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.95 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355180

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-518
In Commercial Distribution

  • H965355180 ()
  • H965355181 ()
  • 15051684023719 ()

  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 6 French
  • Length: 20 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355170

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-517
In Commercial Distribution

  • H965355170 ()
  • H965355171 ()
  • 15051684023702 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
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