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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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RHYTHMIA HDx™ - 08714729972679

Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20020
In Commercial Distribution

  • 08714729972679 ()
M004RH20020

  • Electrical-only medical device connection cable, reusable

VENDYS II - B546VENDYS1

No Description
ENDOTHELIX, INC.
JK-001V
In Commercial Distribution

  • B546VENDYS1 ()


  • Laser Doppler blood flowmeter

NA - 00763000871987

CART AFR-00013 SYSTEM US
MEDTRONIC, INC.
AFR-00013
In Commercial Distribution

  • 00763000871987 ()


  • Cardiac mapping system

Affera™ Mapping System - 00763000871956

MAPPING SYSTEM AFR-00003 US
MEDTRONIC, INC.
AFR-00003
In Commercial Distribution

  • 00763000871956 ()


  • Cardiac mapping system

NA - 00763000871833

PATCH AFR-00007 LOCATION REF 4PK US
MEDTRONIC, INC.
AFR-00007
In Commercial Distribution

  • 20763000871837 ()
  • 00763000871833 ()


  • Cardiac mapping system reference patch

CardioInsight™ - 00763000045456

SENSOR ARRAY VEST CITVST0004XL US
MEDTRONIC, INC.
CITVST0004XL
In Commercial Distribution

  • 00763000045456 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045449

SENSOR ARRAY VEST CITVST0003L US
MEDTRONIC, INC.
CITVST0003L
In Commercial Distribution

  • 00763000045449 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045432

SENSOR ARRAY VEST CITVST0002M US
MEDTRONIC, INC.
CITVST0002M
In Commercial Distribution

  • 00763000045432 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045425

SENSOR ARRAY VEST CITVST0001S US
MEDTRONIC, INC.
CITVST0001S
In Commercial Distribution

  • 00763000045425 ()


  • Cardiac mapping system electrode array

EnSite Precision™ - 15415067025934

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067025934 ()
  • 05415067025937 ()
EN0020-P

  • Cardiac mapping system reference patch
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