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 Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system
Mapping System Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004OPAL40100
In Commercial Distribution

  • 00191506055301 ()
M004OPAL40100

  • Cardiac mapping system
Ablation Connection Box
BOSTON SCIENTIFIC CORPORATION
M004RA6301US0
In Commercial Distribution

  • 00191506034429 ()
M004RA6301US0

  • Cardiac mapping system
Ablation Connection Box (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA65010
In Commercial Distribution

  • 00191506020804 ()
M004RA65010

  • Cardiac mapping system
Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

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

  • 00763000118280 ()


  • 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
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