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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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Stellarex - 00813132023171

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX040040135
In Commercial Distribution

  • 00813132023171 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023164

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX060120080
In Commercial Distribution

  • 00813132023164 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023157

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX060080080
In Commercial Distribution

  • 00813132023157 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023140

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX060040080
In Commercial Distribution

  • 00813132023140 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023133

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132023133 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023126

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132023126 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023119

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132023119 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023102

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX040120080
In Commercial Distribution

  • 00813132023102 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023096

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX040080080
In Commercial Distribution

  • 00813132023096 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023089

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX040040080
In Commercial Distribution

  • 00813132023089 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040040080

  • Peripheral angioplasty balloon catheter, drug-coated

SOLACE Sacroiliac Fixation System - 00818345029187

Pin Holder
XENIX MEDICAL LLC
SS1-A1-000036
In Commercial Distribution

  • 00818345029187 ()
SS1-A1-000036

  • Surgical flat-nosed pliers

SOLACE Sacroiliac Fixation System - 00818345028531

Pin and Dilator Holder
XENIX MEDICAL LLC
SS1-A1-000035
In Commercial Distribution

  • 00818345028531 ()


  • Surgical flat-nosed pliers

Tecomet - 00841435120808

Locking Pliers
TECOMET INC.
2421-27-000
In Commercial Distribution

  • 00841435120808 ()


  • Surgical flat-nosed pliers

F88 - 08881300750107

Single Luer Stopcock
SG ENDOSCOPY PTE. LTD.
0503388001
In Commercial Distribution

  • 08881300750046 ()
  • 08881300750107 ()
0503388001

  • Endoscope working-channel valve, reusable

Tecomet - 00841435111219

Pliers
TECOMET INC.
48604
In Commercial Distribution

  • 00841435111219 ()


  • Surgical flat-nosed pliers

ILLUMISITE - 10884521723818

Endobronchial Procedure Kit 180 Catheter
Covidien LP
ILS-1800-KT
In Commercial Distribution

  • 10884521723818 ()

  • Length: 1070 Millimeter
  • Angle: 180 degree
  • Outer Diameter: 2.7 Millimeter


  • Endoscope working-channel valve, single-use

Anmuth Medical International - 08403207010223

MAYO Wire Twister 15cm/6"
Anmuth Medical International, LLC
39-554-15TC
In Commercial Distribution

  • 08403207010223 ()

  • Length: 6 Inch
39-554-15TC

  • Surgical flat-nosed pliers

Symmetry Surgical - 00887482055250

Symmetry® Pliers; Serrated; Flat Nose; 5 1/2 in
SYMMETRY SURGICAL INC.
14-4614
In Commercial Distribution

  • 00887482055250 ()

  • Length: 5.5 Inch
14-4614

  • Surgical flat-nosed pliers

Anmuth Medical International - 08403207010216

Wire Twister, Blunt Jaw TC, 6.25"
Anmuth Medical International, LLC
39-553-16
In Commercial Distribution

  • 08403207010216 ()

  • Length: 6.25 Inch
39-553-16

  • Surgical flat-nosed pliers

Anmuth Medical International - 08403207010087

Wire Twister & Tightener 6.25"
Anmuth Medical International, LLC
39-541-17TC
In Commercial Distribution

  • 08403207010087 ()

  • Length: 6.25 Inch
39-541-17TC

  • Surgical flat-nosed pliers

Symmetry Surgical - 00887482055243

Symmetry® Pliers, Flat Nose, 2.0 mm Tip, 6 in, 152 mm
SYMMETRY SURGICAL INC.
14-4600
In Commercial Distribution

  • 00887482055243 ()

  • Length: 6 Inch
  • Width: 2 Millimeter
14-4600

  • Surgical flat-nosed pliers

Anmuth Medical International - 08403207010230

Wire Bender
Anmuth Medical International, LLC
39-555-15TC
In Commercial Distribution

  • 08403207010230 ()

  • Length: 6 Inch
39-555-15TC

  • Surgical flat-nosed pliers

Anmuth Medical International - 08403207010155

Mayo Wire Twister 15cm/6"
Anmuth Medical International, LLC
39-546-22TC
In Commercial Distribution

  • 08403207010155 ()

  • Length: 6 Inch
39-546-22TC

  • Surgical flat-nosed pliers

STILLE Pliers - 07332339203801

FLAT PLIERS STILLE 17 cm 6.75 in
Stille AB
105-16015
In Commercial Distribution

  • 07332339203801 ()

  • Length: 17 Centimeter
105-16015

  • Surgical flat-nosed pliers

Symmetry Surgical - 00887482012093

Symmetry® Pliers, Needle Nose, Wire Notch, 6 1/4 in, 158 mm
SYMMETRY SURGICAL INC.
37-4100
In Commercial Distribution

  • 00887482012093 ()

  • Length: 6.25 Inch
37-4100

  • Surgical flat-nosed pliers

Symmetry Surgical - 00887482046937

Symmetry® Pliers, Slip Joint, 6 1/4 in; 160 mm
SYMMETRY SURGICAL INC.
14-5000
In Commercial Distribution

  • 00887482046937 ()

  • Length: 6.25 Inch
14-5000

  • Surgical flat-nosed pliers

SurVeil DCB - 00812339030449

SurVeil DCB 5.0mm x 150mm x 135cm
Surmodics, Inc.
SRV03513505015
In Commercial Distribution

  • 00812339030449 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Diameter: 150 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Symmetry Surgical - 00887482055335

Symmetry® Pliers, Cutter, Flat Nose, 3.5 mm Tip, 6 1/2 in, 165 mm
SYMMETRY SURGICAL INC.
14-5065
In Commercial Distribution

  • 00887482055335 ()

  • Length: 6.5 Inch
  • Width: 3.5 Millimeter
14-5065

  • Surgical flat-nosed pliers

Sapphire II PRO Balloon Dilatation Catheter - 06934955950087

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501201512
In Commercial Distribution

  • 06934955950087 ()

  • Balloon Diameter: 1.25 Millimeter
  • Balloon Length: 15 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950070

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501201012
In Commercial Distribution

  • 06934955950070 ()

  • Balloon Diameter: 1.25 Millimeter
  • Balloon Length: 10 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950063

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501200812
In Commercial Distribution

  • 06934955950063 ()

  • Balloon Diameter: 1.25 Millimeter
  • Balloon Length: 8 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950056

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501200512
In Commercial Distribution

  • 06934955950056 ()

  • Balloon Diameter: 1.25 Millimeter
  • Balloon Length: 5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950049

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501001512
In Commercial Distribution

  • 06934955950049 ()

  • Balloon Diameter: 1 Millimeter
  • Balloon Length: 15 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950032

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501001012
In Commercial Distribution

  • 06934955950032 ()

  • Balloon Diameter: 1 Millimeter
  • Balloon Length: 10 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950025

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501000812
In Commercial Distribution

  • 06934955950025 ()

  • Balloon Diameter: 1 Millimeter
  • Balloon Length: 8 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II PRO Balloon Dilatation Catheter - 06934955950018

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
501000512
In Commercial Distribution

  • 06934955950018 ()

  • Balloon Diameter: 1 Millimeter
  • Balloon Length: 5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942457

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
240-203-5UU
In Commercial Distribution

  • 06934955942457 ()

  • Length: 20 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942440

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
240-153-5UU
In Commercial Distribution

  • 06934955942440 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 15 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942433

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
240-103-5UU
In Commercial Distribution

  • 06934955942433 ()

  • Length: 10 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942426

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
235-303-5UU
In Commercial Distribution

  • 06934955942426 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 30 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
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