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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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A1c-Cellular - 00844509000938

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control

Pointe Scientific, Inc. - 00811727011336

Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control

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

Sapphire II Pro - 06934955942419

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

Sapphire II Pro - 06934955942402

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

Sapphire II Pro - 06934955942396

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

Sapphire II Pro - 06934955942389

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

Sapphire II Pro - 06934955942372

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

Sapphire II Pro - 06934955942365

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
232-103-5UU
In Commercial Distribution

  • 06934955942365 ()

  • Outer Diameter: 3.25 Millimeter
  • Length: 10 Millimeter


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