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

  • 08403207010230 ()

  • Length: 6 Inch
39-555-15TC

  • Surgical flat-nosed pliers
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
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® 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® 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
Pin Holder
XENIX MEDICAL LLC
SS1-A1-000036
In Commercial Distribution

  • 00818345029187 ()
SS1-A1-000036

  • Surgical flat-nosed pliers
Pin and Dilator Holder
XENIX MEDICAL LLC
SS1-A1-000035
In Commercial Distribution

  • 00818345028531 ()


  • Surgical flat-nosed pliers
Locking Pliers
TECOMET INC.
2421-27-000
In Commercial Distribution

  • 00841435120808 ()


  • Surgical flat-nosed pliers
Single Luer Stopcock
SG ENDOSCOPY PTE. LTD.
0503388001
In Commercial Distribution

  • 08881300750046 ()
  • 08881300750107 ()
0503388001

  • Endoscope working-channel valve, reusable
Pliers
TECOMET INC.
48604
In Commercial Distribution

  • 00841435111219 ()


  • Surgical flat-nosed pliers
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
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
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
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
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
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
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
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
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
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
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
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
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
235-203-5UU
In Commercial Distribution

  • 06934955942419 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
235-153-5UU
In Commercial Distribution

  • 06934955942402 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 15 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
235-103-5UU
In Commercial Distribution

  • 06934955942396 ()

  • Length: 10 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
232-203-5UU
In Commercial Distribution

  • 06934955942389 ()

  • Outer Diameter: 3.25 Millimeter
  • Length: 20 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
232-153-5UU
In Commercial Distribution

  • 06934955942372 ()

  • Length: 15 Millimeter
  • Outer Diameter: 3.25 Millimeter


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