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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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Safire™ Blu™ SP - 05414734310765

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A402872
Not in Commercial Distribution

  • 05414734310765 ()

  • Catheter Gauge: 7 French
A402872

  • Cardiac radio-frequency ablation system catheter

Safire™ Blu™ SP - 05414734310758

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A402870
Not in Commercial Distribution

  • 05414734310758 ()

  • Catheter Gauge: 7 French
A402870

  • Cardiac radio-frequency ablation system catheter

Safire™ Blu™ SP - 05414734310741

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A402871
Not in Commercial Distribution

  • 05414734310741 ()

  • Catheter Gauge: 7 French
A402871

  • Cardiac radio-frequency ablation system catheter

Safire™ Blu™ SP - 05414734310734

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A402869
Not in Commercial Distribution

  • 05414734310734 ()

  • Catheter Gauge: 7 French
A402869

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734310680

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path SP
Not in Commercial Distribution

  • 05414734310680 ()

  • Catheter Gauge: 7 French
A088049

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734310673

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path™ SP
Not in Commercial Distribution

  • 05414734310673 ()

  • Catheter Gauge: 7 French
A088048

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734310666

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path SP
Not in Commercial Distribution

  • 05414734310666 ()

  • Catheter Gauge: 7 French
A088047

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734310659

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path SP
Not in Commercial Distribution

  • 05414734310659 ()

  • Catheter Gauge: 7 French
A088046

  • Cardiac radio-frequency ablation system catheter

SJM™ - 05414734309110

Electrophysiology Cable
IRVINE BIOMEDICAL, INC.
IBI-85809
In Commercial Distribution

  • 05414734309110 ()

  • Length: 5 Feet
IBI-85809

  • Electrical-only medical device connection cable, reprocessed

NA - 05414734309080

Electrophysiology Cable 1779
IRVINE BIOMEDICAL, INC.
IBI-85786
In Commercial Distribution

  • 05414734309080 ()

  • Length: 20 Feet
IBI-85786

  • Electrical-only medical device connection cable, reusable
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