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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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AMS 700 CX MS Pump - 00878953003870

AMS 700 Inflatable Penile Prosthesis, Preconnected 1 MS Pump to 2 CX Cylinders, Penoscrotal
BOSTON SCIENTIFIC CORPORATION
72404284
In Commercial Distribution

  • 00878953003870 ()

  • Length: 24 Centimeter
  • Outer Diameter: 12 Millimeter
72404284

  • Inflatable penile prosthesis

Sentimag - 15060391210350

Thin Probe for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Thin Probe
In Commercial Distribution

  • 15060391210350 ()
SMP03T

  • Magnetic metal detector

Sentimag - 15060391210343

Probe checker for Sentimag Gen 3 Probe
ENDOMAGNETICS LTD
Gen 3 Probe Checker
In Commercial Distribution

  • 15060391210343 ()
SMC03

  • Magnetic metal detector

Sentimag - 15060391210336

Footswitch for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Footswitch
In Commercial Distribution

  • 15060391210336 ()
SMA03

  • Magnetic metal detector

Sentimag - 15060391210329

Standard Probe for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Probe
In Commercial Distribution

  • 15060391210329 ()
SMP03

  • Magnetic metal detector

Sentimag - 15060391210312

Sentimag Gen 3 Base Unit
ENDOMAGNETICS LTD
Gen 3
In Commercial Distribution

  • 15060391210312 ()
SMB03

  • Magnetic metal detector

Advin Multi-Drug Screen Test - B115ABCARDA10141

BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10141 ()
  • B115ABCARDA10140 ()
ABCardA-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Advin Multi-Drug Screen Test - B115ABCARD10141

BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10141 ()
  • B115ABCARD10140 ()
ABCard-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

INTERCEPT Blood System - 18717953196948

INTERCEPT INT100 Illuminator
CERUS CORPORATION
INT100
In Commercial Distribution

  • 18717953196948 ()


  • Pathogen inactivation/reduction 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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