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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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Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
ATRICURE, INC.
OSL2
In Commercial Distribution

  • 00818354010558 ()
A000432

  • Cardiac radio-frequency ablation system generator
Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
ATRICURE, INC.
OLL2
In Commercial Distribution

  • 00818354010503 ()
A000362

  • Cardiac radio-frequency ablation system generator
Footswitch ASU2/ASU3
ATRICURE, INC.
ASU
In Commercial Distribution

  • 00818354010312 ()
A000049

  • Cardiac radio-frequency ablation system generator
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Analog Output Cable
ST. JUDE MEDICAL, INC.
PN-001427
In Commercial Distribution

  • 07640157990217 ()
PN-001427

  • Electrical-only medical device connection cable, reusable
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
Mount
ST. JUDE MEDICAL, INC.
PN-004511
In Commercial Distribution

  • 07640157990187 ()
PN-004511

  • Medical device service rail clamp
RF Cable
ST. JUDE MEDICAL, INC.
PN-004515
In Commercial Distribution

  • 07640157990064 ()
PN-004515

  • Electrical-only medical device connection cable, reusable
RF Cable
ST. JUDE MEDICAL, INC.
PN-004514
In Commercial Distribution

  • 07640157990057 ()
PN-004514

  • Electrical-only medical device connection cable, reusable
Contact Force Ablation Catheter
ST. JUDE MEDICAL, INC.
PN-004075
In Commercial Distribution

  • 07640157990040 ()

  • Catheter Gauge: 7 French
PN-004075

  • Cardiac radio-frequency ablation system catheter
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