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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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Peel-Away Introducer with Hemostatic Valve and Side Port, 9F
Oscor Inc.
ASU0913B5
In Commercial Distribution

  • 10885672104549 ()
  • 00885672104542 ()

  • Sheath Length 13 cm
  • Syringe 10 cc
  • Lumen/Inner Diameter: 3 Millimeter
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Dilator Length 18 cm
  • Needle Gauge: 18 Gauge
ASU0913B5

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer with Hemostatic Valve and Side Port, 8.5F
Oscor Inc.
ASU8513B5
In Commercial Distribution

  • 10885672104532 ()
  • 00885672104535 ()

  • Sheath Length 13 cm
  • Dilator Length 18 cm
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 2.9 Millimeter
  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
ASU8513B5

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer with Hemostatic Valve and Side Port, 8F
Oscor Inc.
ASU0813B5
In Commercial Distribution

  • 10885672104525 ()
  • 00885672104528 ()

  • Lumen/Inner Diameter: 2.7 Millimeter
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Dilator Length 18 cm
  • Sheath Length 13 cm
  • Needle Gauge: 18 Gauge
ASU0813B5

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer with Hemostatic Valve and Side Port, 7F
Oscor Inc.
ASU0713B5
In Commercial Distribution

  • 10885672104518 ()
  • 00885672104511 ()

  • Lumen/Inner Diameter: 2.3 Millimeter
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
  • Dilator Length 18 cm
  • Sheath Length 13 cm
ASU0713B5

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer with Hemostatic Valve and Side Port, 6F
Oscor Inc.
ASU0613B5
In Commercial Distribution

  • 10885672104501 ()
  • 00885672104504 ()

  • Sheath Length 13 cm
  • Lumen/Inner Diameter: 2.1 Millimeter
  • Dilator Length 18 cm
  • Syringe 10 cc
  • Needle Gauge: 18 Gauge
  • Guidewire - Length: 50 cm, OD: 0.038 in
ASU0613B5

  • Vascular catheter introduction set, nonimplantable
Adelante SafeSheath Ultra Lite, 11F
Oscor Inc.
ASUP111318
In Commercial Distribution

  • 10885672103504 ()
  • 00885672103507 ()

  • Sheath Length 13 cm
  • Guidewire - Length: 50 cm, OD: 0.038 in
  • Dilator Length 18 cm
  • Syringe 10 cc
  • Needle Gauge: 18 Gauge
ASUP111318

  • Vascular catheter introduction set, nonimplantable
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, 10.5F
Oscor Inc.
AP10516
In Commercial Distribution

  • 00836559006800 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
  • Needle Gauge: 18 Gauge
  • Dilator Length 19 cm
  • Syringe 10 cc
  • Guidewire Length 50 cm, OD: 0.038 in
  • Sheath Length 16 cm
AP10516

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 10F
Oscor Inc.
AP10016
In Commercial Distribution

  • 00836559006794 ()

  • Lumen/Inner Diameter: 3.3 Millimeter
  • Dilator Length 19 cm
  • Needle Gauge: 18 Gauge
  • Guidewire Length 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Sheath Length 16 cm
AP10016

  • Vascular catheter introduction set, nonimplantable
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