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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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MEDINOL LTD.
NXL30008US
In Commercial Distribution

  • 07290107010863 ()

  • Length: 8 Millimeter
  • Outer Diameter: 3.0 Millimeter


  • Bare-metal coronary artery stent
No Description
MEDINOL LTD.
NXL40033US
In Commercial Distribution

  • 07290107011068 ()

  • Length: 33 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Bare-metal coronary artery stent
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution

  • 00850008997020 ()


  • Implantable pulmonary artery pressure monitoring system
The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.
Shockwave Medical, Inc.
825DP
In Commercial Distribution

IVLCC

  • Electrical catheter connection cable/switch
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

IVLGCCD

  • Intravascular lithotripsy system balloon catheter, coronary
  • Intravascular lithotripsy system balloon catheter, peripheral
  • Intravascular lithotripsy system generator
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
Xvivo Perfusion AB
19046
In Commercial Distribution

  • 07350069520401 ()
19046

  • Lung donor-organ preservation/evaluation system lung-interface set
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
Xvivo Perfusion AB
19035
Not in Commercial Distribution

  • 07350069520142 ()
19035

  • Lung donor-organ preservation/evaluation system lung-interface set
A Kit for 10 Neuro treatment (Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA). Kit content: Part Description SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) X 2 units
INSIGHTEC LTD
SET001102 Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461887 ()
SET001102

  • Therapeutic oncological/gynaecological ultrasound system
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

  • M732IVLGCCD0 ()
IVLGCCD

  • Ultrasound thrombolysis system control unit
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825DP
In Commercial Distribution

  • M732IVLGCC0 ()
IVLGCC

  • Ultrasound thrombolysis system control unit
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