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 Class Implantable

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Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system
Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system
MAPPING SYSTEM CIT200 US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00763000118280 ()


  • Cardiac mapping system
CART AFR-00013 SYSTEM US
MEDTRONIC, INC.
AFR-00013
In Commercial Distribution

  • 00763000871987 ()


  • Cardiac mapping system
MAPPING SYSTEM AFR-00003 US
MEDTRONIC, INC.
AFR-00003
In Commercial Distribution

  • 00763000871956 ()


  • Cardiac mapping system
RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution

  • 05414734210881 ()
H421088

  • Electrical-only medical device connection cable, reusable
  • Cardiac mapping system
Includes GRIP2-High, GRIP2-Mid, GRIP2-Low and GRIP2 Maps, and 2 Grip 4256E Sensors
Tekscan, Inc.
Grip VersaTek Add-on
In Commercial Distribution

  • B970AFFSG0 ()
AFFS-G

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, I-Scan Software CD with 2 K-Scan Sensor maps, Sensor Carrying Case, System Carrying Case, and System Manual. 1 Day of Training (USA Only). Sensor selection: Choice of up to 5 sensors corresponding to the maps chosen above (value up to $1,000)
Tekscan, Inc.
K-Scan Joint Pressure Measurement System
In Commercial Distribution

  • B970KE10 ()
KE1

  • Body-surface pressure mapping system
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