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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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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

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
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