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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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1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire
REMINGTON MEDICAL, INC.
7010
In Commercial Distribution

  • 10813079020209 ()
  • 00813079020202 ()
  • 20813079020206 ()

  • Catheter Gauge: 10 French
7010

  • Vascular catheter introduction set, nonimplantable
1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire
REMINGTON MEDICAL, INC.
7009
In Commercial Distribution

  • 20813079020190 ()
  • 10813079020193 ()
  • 00813079020196 ()

  • Catheter Gauge: 9 French
7009

  • Vascular catheter introduction set, nonimplantable
1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire
REMINGTON MEDICAL, INC.
7008
In Commercial Distribution

  • 10813079020186 ()
  • 00813079020189 ()
  • 20813079020183 ()

  • Catheter Gauge: 8 French
7008

  • Vascular catheter introduction set, nonimplantable
1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire
REMINGTON MEDICAL, INC.
7007
In Commercial Distribution

  • 10813079020179 ()
  • 00813079020172 ()
  • 20813079020176 ()

  • Catheter Gauge: 7 French
7007

  • Vascular catheter introduction set, nonimplantable
1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire
REMINGTON MEDICAL, INC.
7006
In Commercial Distribution

  • 10813079020162 ()
  • 00813079020165 ()
  • 20813079020169 ()

  • Catheter Gauge: 6 French
7006

  • Vascular catheter introduction set, nonimplantable
Occlusion Balloon Catheter, 6F
Oscor Inc.
V0612015
Not in Commercial Distribution

  • 00836559007111 ()

  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
  • Required Syringe Size 2.0 cc
  • Length: 120 Centimeter
V0612015

  • Cardiac sizing catheter
Occlusion Balloon Catheter, 6F
Oscor Inc.
V068015
Not in Commercial Distribution

  • 00836559007098 ()

  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
V068015

  • Cardiac sizing catheter
Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510015
Not in Commercial Distribution

  • 00836559007081 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Length: 100 Centimeter
  • Required Syringe Size 2.0 cc
V0510015

  • Cardiac sizing catheter
Occlusion Balloon Catheter, 5F
Oscor Inc.
V058015
Not in Commercial Distribution

  • 00836559007074 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
V058015

  • Cardiac sizing catheter
Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510010
Not in Commercial Distribution

  • 00836559006916 ()

  • Length: 100 Centimeter
  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
V0510010

  • Cardiac sizing catheter
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