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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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LINEUM® OCT SPINE SYSTEM - 00880304958685

No Description
BIOMET SPINE LLC
14-524396
In Commercial Distribution

  • 00880304958685 ()

  • LINEUM 3.5MM X 46MM CC SMOOTH TRANSLATING SCREW
14-524396

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM® OCT SPINE SYSTEM - 00880304958678

No Description
BIOMET SPINE LLC
14-524398
In Commercial Distribution

  • 00880304958678 ()

  • LINEUM 3.5MM X 48MM CC SMOOTH TRANSLATING SCREW
14-524398

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM® OCT SPINE SYSTEM - 00880304958661

No Description
BIOMET SPINE LLC
14-524400
In Commercial Distribution

  • 00880304958661 ()

  • LINEUM 3.5MM X 50MM CC SMOOTH TRANSLATING SCREW
14-524400

  • Bone-screw internal spinal fixation system, non-sterile

Disposable Tear-Away Vascular Introducer Set - 00813079020219

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.
7011
In Commercial Distribution

  • 20813079020213 ()
  • 10813079020216 ()
  • 00813079020219 ()

  • Catheter Gauge: 11 French
7011

  • Vascular catheter introduction set, nonimplantable

Disposable Tear-Away Vascular Introducer Set - 00813079020202

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

Disposable Tear-Away Vascular Introducer Set - 00813079020196

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

Disposable Tear-Away Vascular Introducer Set - 00813079020189

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

Disposable Tear-Away Vascular Introducer Set - 00813079020172

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

Disposable Tear-Away Vascular Introducer Set - 00813079020165

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

Venos Occlusion Balloon Catheter - 00836559007111

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
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