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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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Therapy™ - 05414734308571

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-84309
In Commercial Distribution

  • 05414734308571 ()

  • Catheter Gauge: 7 French
IBI-84309

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734308564

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-84308
In Commercial Distribution

  • 05414734308564 ()

  • Catheter Gauge: 7 French
IBI-84308

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307598

8mm Tip Thermistor Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83445
In Commercial Distribution

  • 05414734307598 ()

  • Catheter Gauge: 7 French
IBI-83445

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307581

8mm Tip Thermistor Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83444
Not in Commercial Distribution

  • 05414734307581 ()

  • Catheter Gauge: 7 French
IBI-83444

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307567

8mm Tip Thermistor Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83442
In Commercial Distribution

  • 05414734307567 ()

  • Catheter Gauge: 7 French
IBI-83442

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307550

8mm Tip Thermistor Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83441
Not in Commercial Distribution

  • 05414734307550 ()

  • Catheter Gauge: 7 French
IBI-83441

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307024

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Dual-8™
Not in Commercial Distribution

  • 05414734307024 ()

  • Catheter Gauge: 7 French
IBI-83375

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307017

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83374
In Commercial Distribution

  • 05414734307017 ()

  • Catheter Gauge: 7 French
IBI-83374

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734307000

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83373
In Commercial Distribution

  • 05414734307000 ()

  • Catheter Gauge: 7 French
IBI-83373

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734306997

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83372
In Commercial Distribution

  • 05414734306997 ()

  • Catheter Gauge: 7 French
IBI-83372

  • Cardiac radio-frequency ablation system catheter
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