SEARCH RESULTS FOR: !➧주식DB구합니다◀✅텔레그램thinkDB(72413 results)

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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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CardioSight™ Reader - 00643169312098

MON 2020A2 CARDIOSIGHT 60601 3ED USA
MEDTRONIC, INC.
2020A2
In Commercial Distribution

  • 00643169312098 ()


  • Cardiac pulse generator reader, home-use

MEDTRONIC CARELINK EXPRESS™ - 00643169312081

MON 2020C2 CARELINK 60601 3ED USA
MEDTRONIC, INC.
2020C2
In Commercial Distribution

  • 00643169312081 ()


  • Cardiac pulse generator reader, professional

i-FACTOR™ Peptide Enhanced Bone Graft - 00850001680028

i-FACTOR™ Putty, 5.0 cc Syringe
Cerapedics Inc.
700-050
In Commercial Distribution

700-050

  • Bone matrix implant, animal-derived, bioabsorbable

i-FACTOR Peptide Enhanced Bone Graft - 00850001680011

i-FACTOR Putty, 2.5cc Syringe
Cerapedics Inc.
700-025
In Commercial Distribution

700-025

  • Bone matrix implant, animal-derived, bioabsorbable

i-FACTOR Peptide Enhanced Bone Graft - 00850001680004

i-FACTOR Putty, 1.0cc Syringe
Cerapedics Inc.
700-010
In Commercial Distribution

700-010

  • Bone matrix implant, animal-derived, bioabsorbable

VenaSeal™ - 00643169986268

VS-402 VENASEAL CLOSURE SYSTEM X5
MEDTRONIC, INC.
VS-402
Not in Commercial Distribution

  • 20643169986262 ()
  • 00643169986268 ()


  • Varicose vein adhesive-treatment kit

Cordella Data Analysis Platform - 00850008997051

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

Cordella Calibration Equipment - 00850008997020

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

myCordella Handheld Patient Reader - 00850008997013

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

Cordella Sensor Delivery Kit - 00850008997006

The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution

  • 00850008997006 ()


  • Implantable pulmonary artery pressure monitoring system
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