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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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LABSYSTEM™ PRO - 08714729883654

VGA Image Capture Option Board For LABSYSTEM™ PRO EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420019520
In Commercial Distribution

  • 08714729883654 ()


  • Multiple physiological signal amplifier

Rhythmia™ Mapping System - 08714729880318

Magnetic Tracking System Kit
BOSTON SCIENTIFIC CORPORATION
M004RBLMR100
In Commercial Distribution

  • 08714729880318 ()


  • Electromagnetic surgical navigation device tracking system

Rhythmia™ Mapping System - 08714729863199

Rhythmia Global Install Bundle
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL10
In Commercial Distribution

  • 08714729863199 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729972679

Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20020
In Commercial Distribution

  • 08714729972679 ()
M004RH20020

  • Electrical-only medical device connection cable, reusable

IBP Cable Kit - 08714729986089

No Description
BOSTON SCIENTIFIC CORPORATION
H7495554280
In Commercial Distribution

  • 08714729986089 ()
H7495554280

  • Cardiovascular ultrasound imaging system

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

CER-S - B972CCZ12050482080

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software

CER-S - B972CCZ12050482050

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482050 ()
CCZ1205048205

  • Electrocardiographic long-term ambulatory recording analyser application software
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