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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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SJM™ Masters Series Hemashield™ - 05414734027762

No Description
ST. JUDE MEDICAL, INC.
CAVGJ-514 00
Not in Commercial Distribution

  • 05414734027762 ()

  • Outer Diameter: 19 Millimeter
19CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

Safire™ TX - 05414734300278

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402838
Not in Commercial Distribution

  • 05414734300278 ()

  • Catheter Gauge: 7 French
402838

  • Cardiac radio-frequency ablation system catheter

Safire™ TX - 05414734300261

Catheter Extension Cable Stockert Generator 1740-SW
IRVINE BIOMEDICAL, INC.
402579
In Commercial Distribution

  • 05414734300261 ()

  • Length: 2.5 Meter
402579

  • Electrical-only medical device connection cable, reprocessed

Safire™ TX - 05414734300254

Catheter Extension Cable IBI Generator 1642
IRVINE BIOMEDICAL, INC.
402578
In Commercial Distribution

  • 05414734300254 ()

  • Length: 2.5 Meter
402578

  • Electrical-only medical device connection cable, reprocessed

Safire™ TX - 05414734300247

Catheter Extension Cable EPT Generator 1779-SE
IRVINE BIOMEDICAL, INC.
402577
In Commercial Distribution

  • 05414734300247 ()

  • Length: 2.5 Meter
402577

  • Electrical-only medical device connection cable, reprocessed

Safire™ TX - 05414734300193

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402843
In Commercial Distribution

  • 05414734300193 ()

  • Catheter Gauge: 7 French
402843

  • Cardiac radio-frequency ablation system catheter

Safire™ TX - 05414734300186

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402842
In Commercial Distribution

  • 05414734300186 ()

  • Catheter Gauge: 7 French
402842

  • Cardiac radio-frequency ablation system catheter

Safire™ TX - 05414734300179

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402841
In Commercial Distribution

  • 05414734300179 ()

  • Catheter Gauge: 7 French
402841

  • Cardiac radio-frequency ablation system catheter

Safire™ TX - 05414734300162

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402840
In Commercial Distribution

  • 05414734300162 ()

  • Catheter Gauge: 7 French
402840

  • Cardiac radio-frequency ablation system catheter

Ovation iX Iliac Stent Graft - 00850007370992

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL141080-J
In Commercial Distribution

  • 00850007370992 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 80 Millimeter
TV-IL141080-J

  • Abdominal aorta endovascular stent-graft
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