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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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Spectra - 08809108011343

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 18809108011340 ()
  • 08809108011343 ()
  • 28809108011347 ()


  • Breast pump, electric

ASSORTED BRANDS - 00193033543900

No Description
FGX INTERNATIONAL INC.
DL5812/9.FTG
In Commercial Distribution

  • 00193033543900 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033543894

No Description
FGX INTERNATIONAL INC.
DL5816/9.FTG
In Commercial Distribution

  • 00193033543894 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033511572

No Description
FGX INTERNATIONAL INC.
DL5660/9.CGR
In Commercial Distribution

  • 00193033511572 ()


  • Tinted non-prescription spectacles

Boule Con-Diff Tri-Level - 00812137010230

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control

ASSORTED BRANDS - 00193033448052

No Description
FGX INTERNATIONAL INC.
DL5582/9.FTG
In Commercial Distribution

  • 00193033448052 ()


  • Tinted non-prescription spectacles

MulTipeg™ - 07350096321194

No Description
Integration Diagnostics Sweden AB
MulTipeg™ 9
In Commercial Distribution

  • 07350096321194 ()
55019

  • Multimeter

PRO-Kinetic Energy - 07640130434851

No Description
Biotronik AG
3.5/9/140
In Commercial Distribution

  • 07640130434851 ()

  • Length: 9 mm
  • Diameter: 3.5 mm
  • Usable Length: 140 cm
383864

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434820

No Description
Biotronik AG
2.5/9/140
In Commercial Distribution

  • 07640130434820 ()

  • Usable Length: 140 cm
  • Length: 9 mm
  • Diameter: 2.5 mm
383861

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434813

No Description
Biotronik AG
2.25/9/140
In Commercial Distribution

  • 07640130434813 ()

  • Usable Length: 140 cm
  • Diameter: 2.25 mm
  • Length: 9 mm
383860

  • Bare-metal coronary artery stent

Passeo-35 - 07640130434523

No Description
Biotronik AG
9/80/130
Not in Commercial Distribution

  • 07640130434523 ()

  • Usable Length: 130 cm
  • Diameter: 9 mm
  • Length: 80 mm
383270

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434486

No Description
Biotronik AG
9/60/130
Not in Commercial Distribution

  • 07640130434486 ()

  • Diameter: 9 mm
  • Usable Length: 130 cm
  • Length: 60 mm
383266

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434424

No Description
Biotronik AG
9/20/130
Not in Commercial Distribution

  • 07640130434424 ()

  • Usable Length: 130 cm
  • Diameter: 9 mm
  • Length: 20 mm
383260

  • Peripheral angioplasty balloon catheter, basic

Astron - 07640130412460

No Description
Biotronik AG
9/80/130
In Commercial Distribution

  • 07640130412460 ()

  • Length: 80 mm
  • Usable Length: 130 cm
  • Diameter: 9 mm
364671

  • Peripheral artery stent, bare-metal

Astron - 07640130412453

No Description
Biotronik AG
9/60/130
In Commercial Distribution

  • 07640130412453 ()

  • Length: 60 mm
  • Diameter: 9 mm
  • Usable Length: 130 cm
364670

  • Peripheral artery stent, bare-metal

Astron - 07640130412446

No Description
Biotronik AG
9/40/130
In Commercial Distribution

  • 07640130412446 ()

  • Length: 40 mm
  • Usable Length: 130 cm
  • Diameter: 9 mm
364669

  • Peripheral artery stent, bare-metal

Astron - 07640130412439

No Description
Biotronik AG
9/30/130
In Commercial Distribution

  • 07640130412439 ()

  • Length: 30 mm
  • Diameter: 9 mm
  • Usable Length: 130 cm
364668

  • Peripheral artery stent, bare-metal

Astron - 07640130412316

No Description
Biotronik AG
9/80/72
In Commercial Distribution

  • 07640130412316 ()

  • Diameter: 9 mm
  • Length: 80 mm
  • Usable Length: 72 cm
364656

  • Peripheral artery stent, bare-metal

Astron - 07640130412293

No Description
Biotronik AG
9/40/72
In Commercial Distribution

  • 07640130412293 ()

  • Usable Length: 72 cm
  • Length: 40 mm
  • Diameter: 9 mm
364654

  • Peripheral artery stent, bare-metal

Astron - 07640130412286

No Description
Biotronik AG
9/30/72
In Commercial Distribution

  • 07640130412286 ()

  • Length: 30 mm
  • Usable Length: 72 cm
  • Diameter: 9 mm
364653

  • Peripheral artery stent, bare-metal

Passeo-35 - 07640119558219

No Description
Biotronik AG
9/40/80
Not in Commercial Distribution

  • 07640119558219 ()

  • Usable Length: 80 cm
  • Length: 40 mm
  • Diameter: 9 mm
357292

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640119558158

No Description
Biotronik AG
9/20/80
Not in Commercial Distribution

  • 07640119558158 ()

  • Diameter: 9 mm
  • Usable Length: 80 cm
  • Length: 20 mm
357286

  • Peripheral angioplasty balloon catheter, basic

PRO-Kinetic Energy - 07640130434868

No Description
Biotronik AG
4.0/9/140
In Commercial Distribution

  • 07640130434868 ()

  • Length: 9 mm
  • Diameter: 4 mm
  • Usable Length: 140 cm
383865

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434844

No Description
Biotronik AG
3.0/9/140
In Commercial Distribution

  • 07640130434844 ()

  • Usable Length: 140 cm
  • Diameter: 3 mm
  • Length: 9 mm
383863

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434837

No Description
Biotronik AG
2.75/9/140
In Commercial Distribution

  • 07640130434837 ()

  • Usable Length: 140 cm
  • Diameter: 2.75 mm
  • Length: 9 mm
383862

  • Bare-metal coronary artery stent

Passeo-35 - 07640130434448

No Description
Biotronik AG
9/40/130
Not in Commercial Distribution

  • 07640130434448 ()

  • Usable Length: 130 cm
  • Length: 40 mm
  • Diameter: 9 mm
383262

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434196

No Description
Biotronik AG
9/80/90
Not in Commercial Distribution

  • 07640130434196 ()

  • Length: 80 mm
  • Diameter: 9 mm
  • Usable Length: 90 cm
383237

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434158

No Description
Biotronik AG
9/60/90
Not in Commercial Distribution

  • 07640130434158 ()

  • Usable Length: 90 cm
  • Diameter: 9 mm
  • Length: 60 mm
383233

  • Peripheral angioplasty balloon catheter, basic

Astron - 07640130412309

No Description
Biotronik AG
9/60/72
In Commercial Distribution

  • 07640130412309 ()

  • Diameter: 9 mm
  • Length: 60 mm
  • Usable Length: 72 cm
364655

  • Peripheral artery stent, bare-metal

RCI Optics - G358142006H780

LIMITED BLACK N BLACK COPPER ATB LTD.
RCI Optics
9 Mile Bank
In Commercial Distribution

  • G358142006H780 ()
141806LTD

  • Tinted non-prescription spectacles
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