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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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EverFlex - 00821684033876

Self-Expanding Peripheral Stent System
Covidien LP
PRB35-08-020-080
In Commercial Distribution

  • 00821684033876 ()

  • Catheter Gauge: 6 French
  • Length: 20 Millimeter
  • Outer Diameter: 8 Millimeter
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,6.5 to 7.5,Millimeter;
  • Outer Diameter: 2 Millimeter


  • Peripheral artery stent, bare-metal

EverFlex - 00821684033814

Self-Expanding Peripheral Stent System
Covidien LP
PRB35-07-020-080
In Commercial Distribution

  • 00821684033814 ()

  • Length: 20 Millimeter
  • Catheter Gauge: 6 French
  • Outer Diameter: 2 Millimeter
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;
  • Outer Diameter: 7 Millimeter


  • Peripheral artery stent, bare-metal

EverFlex - 00821684033753

Self-Expanding Peripheral Stent System
Covidien LP
PRB35-06-020-080
In Commercial Distribution

  • 00821684033753 ()

  • Catheter Gauge: 6 French
  • Length: 20 Millimeter
  • Working Length,80,CM;Compatible Guidewire,.035,IN;Lumen Diameter,4.5 to 5.5,MM;
  • Outer Diameter: 2 Millimeter
  • Outer Diameter: 6 Millimeter


  • Peripheral artery stent, bare-metal

GORE TAG Thoracic Branch Endoprosthesis - 00733132654420

TAG TBE THORACIC SIDE BRANCH 20mmX6cm 12mm Heparin
W. L. Gore & Associates, Inc.
TSB122006A
In Commercial Distribution

  • 00733132654420 ()

  • Catheter Gauge: 14 French
  • Length: 6 Centimeter
  • Lumen/Inner Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 20 Millimeter
TSB122006A

  • Aortic arch branch vessel endovascular stent-graft, drug-coated

Lumicell Direct Visualization System (DVS) - 00860008537898

Sterilization Tray
Lumicell, Inc.
900-00209
In Commercial Distribution

  • 00860008537898 ()


  • Device sterilization/disinfection container, reusable

Cool Point™ - 05415067008985

Irrigation Pump
IRVINE BIOMEDICAL, INC.
IBI-89003
In Commercial Distribution

  • 05415067008985 ()
IBI-89003

  • Bedside infusion pump, single-channel

Ampere™ - 05415067005045

Generator Accessories
ST. JUDE MEDICAL, INC.
H700504
In Commercial Distribution

  • 05415067005045 ()
H700504

  • Electrical-only medical device connection cable, reusable

Ampere™ - 05415067005014

Footswitch
ST. JUDE MEDICAL, INC.
H700501
In Commercial Distribution

  • 05415067005014 ()

  • Length: 15 Meter
H700501

  • Foot-switch, electrical

Ampere™ - 05415067005007

Footswitch
ST. JUDE MEDICAL, INC.
H700500
In Commercial Distribution

  • 05415067005007 ()

  • Length: 10 Meter
H700500

  • Foot-switch, electrical

Ampere™ - 05415067004994

Footswitch
ST. JUDE MEDICAL, INC.
H700499
In Commercial Distribution

  • 05415067004994 ()

  • Length: 5 Meter
H700499

  • Foot-switch, electrical
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