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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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IMPLANT G7736247 MP LORDO 7MMX20MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736247
Not in Commercial Distribution

  • 00643169336469 ()

  • Height: 7.0 Millimeter
  • Width: 20.0 Millimeter
  • Depth: 11.4 Millimeter
  • Angle: 6.0 degree


  • Spinal fusion graft kit
IMPLANT G7736267 MP LORDO 7MMX20MMX16MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736267
Not in Commercial Distribution

  • 00643169336452 ()

  • Height: 7.0 Millimeter
  • Width: 20.0 Millimeter
  • Angle: 6.0 degree
  • Depth: 13.4 Millimeter


  • Spinal fusion graft kit
IMPLANT G7736548 MP LORDO 8MMX15MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736548
Not in Commercial Distribution

  • 00643169336438 ()

  • Width: 15.0 Millimeter
  • Height: 8.0 Millimeter
  • Angle: 6.0 degree
  • Depth: 11.4 Millimeter


  • Spinal fusion graft kit
IMPLANT G7736768 MP LORDO 8MMX17MMX16MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736768
Not in Commercial Distribution

  • 00643169336414 ()

  • Angle: 6.0 degree
  • Width: 17.0 Millimeter
  • Height: 8.0 Millimeter
  • Depth: 13.4 Millimeter


  • Spinal fusion graft kit
IMPLANT G7736248 MP LORDO 8MMX20MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736248
Not in Commercial Distribution

  • 00643169336407 ()

  • Height: 8.0 Millimeter
  • Width: 20.0 Millimeter
  • Depth: 11.4 Millimeter
  • Angle: 6.0 degree


  • Spinal fusion graft kit
IMPLANT G7736268 MP LORDO 8MMX20MMX16MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736268
Not in Commercial Distribution

  • 00643169336391 ()

  • Depth: 13.4 Millimeter
  • Height: 8.0 Millimeter
  • Width: 20.0 Millimeter
  • Angle: 6.0 degree


  • Spinal fusion graft kit
IMPLANT G7736549 MP LORDO 9MMX15MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
G7736549
Not in Commercial Distribution

  • 00643169336377 ()

  • Height: 9.0 Millimeter
  • Angle: 6.0 degree
  • Depth: 11.4 Millimeter
  • Width: 15.0 Millimeter


  • Spinal fusion graft kit
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System. The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution

  • 00850008997051 ()


  • Implantable pulmonary artery pressure monitoring system
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 Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System. The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution

  • 00850008997013 ()


  • Implantable pulmonary artery pressure monitoring system
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