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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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Adelante SafeSheath Ultra Lite, 9F
Oscor Inc.
ASUP091318
In Commercial Distribution

  • 10885672103467 ()
  • 00885672103460 ()

  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Dilator Length 18 cm
  • Sheath Length 13 cm
  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
ASUP091318

  • Vascular catheter introduction set, nonimplantable
Adelante SafeSheath Ultra Lite, 8.5F
Oscor Inc.
ASUP851318
In Commercial Distribution

  • 10885672103450 ()
  • 00885672103453 ()

  • Needle Gauge: 18 Gauge
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Dilator Length 18 cm
  • Sheath Length 13 cm
  • Syringe 10 cc
ASUP851318

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 12F
Oscor Inc.
AP12023B5
In Commercial Distribution

  • 10885672100190 ()
  • 00885672100193 ()

  • Lumen/Inner Diameter: 4 Millimeter
  • Guidewire Length 50 cm, OD: 0.038 in
  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
  • Dilator Length 26 cm
  • Sheath Length 23 cm


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 11F
Oscor Inc.
AP11023B5
In Commercial Distribution

  • 10885672100183 ()
  • 00885672100186 ()

  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
  • Guidewire Length 50 cm, OD: 0.038 in
  • Dilator Length 26 cm
  • Sheath Length 23 cm
  • Lumen/Inner Diameter: 3.7 Millimeter


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 10F
Oscor Inc.
AP10023B5
In Commercial Distribution

  • 10885672100176 ()
  • 00885672100179 ()

  • Syringe 10 cc
  • Dilator Length 26 cm
  • Sheath Length 23 cm
  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 3.3 Millimeter
  • Guidewire Length 50 cm, OD: 0.038 in


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 9F
Oscor Inc.
AP09023B5
In Commercial Distribution

  • 10885672100169 ()
  • 00885672100162 ()

  • Guidewire Length 50 cm, OD: 0.038 in
  • Dilator Length 26 cm
  • Sheath Length 23 cm
  • Syringe 10 cc
  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 3 Millimeter


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 8F
Oscor Inc.
AP08023B5
In Commercial Distribution

  • 10885672100152 ()
  • 00885672100155 ()

  • Needle Gauge: 18 Gauge
  • Guidewire Length 50 cm, OD: 0.038 in
  • Dilator Length 26 cm
  • Syringe 10 cc
  • Sheath Length 23 cm
  • Lumen/Inner Diameter: 2.7 Millimeter


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 7F
Oscor Inc.
AP07023B5
In Commercial Distribution

  • 10885672100145 ()
  • 00885672100148 ()

  • Guidewire Length 50 cm, OD: 0.038 in
  • Dilator Length 26 cm
  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 2.3 Millimeter
  • Sheath Length 23 cm
  • Syringe 10 cc


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 12.5F
Oscor Inc.
AP12516B5
In Commercial Distribution

  • 10885672100138 ()
  • 00885672100131 ()

  • Sheath Length 16 cm
  • Syringe 10 cc
  • Guidewire Length 50 cm, OD: 0.038 in
  • Dilator Length 19 cm
  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 4.2 Millimeter


  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 12F
Oscor Inc.
AP12016B5
In Commercial Distribution

  • 10885672100121 ()
  • 00885672100124 ()

  • Guidewire Length 50 cm, OD: 0.038 in
  • Sheath Length 16 cm
  • Lumen/Inner Diameter: 4 Millimeter
  • Syringe 10 cc
  • Dilator Length 19 cm
  • Needle Gauge: 18 Gauge


  • Vascular catheter introduction set, nonimplantable
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