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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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Cosmed Bod Pod Tube and Filter Kit - US & Canada - 00817081022575

Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod - US and Canada
A-M SYSTEMS, LLC
Bod Pod Tube and Filter Kit - US & Canada - 180014
In Commercial Distribution

  • 00817081022582 ()
  • 00817081022575 ()
180014

  • Pulmonary function testing kit

ECG Snap Lead Wires - 00816396021655

ECG Snap Lead Wires, Metallic, 3 Lead Set, AHA, 24 in
IVY BIOMEDICAL SYSTEMS, INC.
590414
In Commercial Distribution

  • 00816396021655 ()

  • Length: 24 Inch
590414

  • Electrocardiographic lead set, reusable

Rhythmlink® - 00816312025958

3 electrode arrays, Disposable Quick Connect Webb Electrode Array [24 pack]
RHYTHMLINK INTERNATIONAL, LLC
MRQW309090615
In Commercial Distribution

  • 10816312025955 ()
  • 00816312025958 ()


  • Analytical scalp electrode, single-use

ProtekSolo - 00814112020449

24 Fr x 60 cm venous cannula with 21 Fr Introducer
CARDIACASSIST, INC.
5140-6024
In Commercial Distribution

  • 00814112020449 ()
5140-6024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Radiance - 00818089021461

CUSTOM KARL STORZ CHINA, 24" RADIANCE G2, W/ SINGLE FIBER, SC-WU24-A1515
Nds Surgical Imaging LLC
90X0581
In Commercial Distribution

  • 00818089021461 ()


  • Image display unit, colour

Radiance - 00818089021454

CUSTOM KARL STORZ CHINA, 24" RADIANCE G2, W/O FIBER, SC-WU24-A1511
Nds Surgical Imaging LLC
90X0580
In Commercial Distribution

  • 00818089021454 ()


  • Image display unit, colour

Radiance - 00818089021447

RADIANCE G2 24", W/ SINGLE FIBER, CUSTOM KARL STORZ GMBH, SC-WU24-A1515
Nds Surgical Imaging LLC
90x0576
In Commercial Distribution

  • 00818089021447 ()


  • Image display unit, colour

Radiance - 00818089021430

RADIANCE G2 24", W/O FIBER, CUSTOM KARL STORZ GMBH, SC-WU24-A1511
Nds Surgical Imaging LLC
90X0575
In Commercial Distribution

  • 00818089021430 ()


  • Image display unit, colour

UROPASS II - 00821925007192

UROPASS II Open Tip Ureteral Stent 6.0 FR X 24 cm
Gyrus ACMI, LLC
5436024
In Commercial Distribution

  • 00821925007192 ()


  • Polymeric ureteral stent

DOUBLE-J - 00821925006553

8.5FR(2.81mm)X 24 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT
Gyrus ACMI, LLC
5209800
In Commercial Distribution

  • 00821925006553 ()


  • Polymeric ureteral stent
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