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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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No Description
EXACT SCIENCES CORPORATION
100029
In Commercial Distribution

  • 00858637005031 ()


  • Nucleic acid extraction/isolation kit IVD
No Description
EXACT SCIENCES CORPORATION
100028
In Commercial Distribution

  • 00858637005000 ()


  • Nucleic acid extraction/isolation kit IVD
Endoscopic Ablation Catheter
CARDIOFOCUS, INC.
18-4000-27A
In Commercial Distribution

  • 00868976000178 ()

  • Catheter Gauge: 12 French
  • Length: 107 Centimeter
18-4000-27A

  • Cardiac ablation laser system beam guide-catheter
Endoscopic Ablation Console (JP)
CARDIOFOCUS, INC.
18-4247
In Commercial Distribution

  • 00868976000161 ()
18-4247

  • Cardiac ablation solid-state laser system
Laser Ablation Console
CARDIOFOCUS, INC.
CF980-E10-US
In Commercial Distribution

  • 00868976000154 ()
18-3055

  • Cardiac ablation solid-state laser system
Balloon Fill Media
CARDIOFOCUS, INC.
18-1342
In Commercial Distribution

  • 00868976000130 ()

  • Total Volume: 95 Milliliter
18-1342

  • Vascular balloon catheter fill-media
Endoscope
CARDIOFOCUS, INC.
18-1447
In Commercial Distribution

  • 00868976000123 ()
18-1447

  • Flexible fibreoptic arterioscope, reusable
Endoscopic Ablation Console (EU)
CARDIOFOCUS, INC.
18-2959
In Commercial Distribution

  • 00868976000116 ()
18-2959

  • Cardiac ablation solid-state laser system
Laser Ablation Balloon Catheter
CARDIOFOCUS, INC.
18-2531-N250
In Commercial Distribution

  • 00868976000109 ()

  • Length: 107 Centimeter
  • Catheter Gauge: 12 French
18-2531-N250

  • Cardiac ablation laser system beam guide-catheter
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100
Not in Commercial Distribution

  • 10868866000032 ()
  • 00868866000035 ()
Sterile-C100

  • Electrode conductive skin pad, single-use
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