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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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RECELL - 00851707004262

RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution

  • 00851707004262 ()
AVRL0102

  • Autologous skin cell grafting kit

Maximo® II CRT-D - 00613994714800

CRT D264TRM MAXIMO II CRT-D US MR DF4
MEDTRONIC, INC.
D264TRM
Not in Commercial Distribution

  • 00613994714800 ()


  • Cardiac resynchronization therapy implantable defibrillator

Consulta® CRT-D - 00613994714701

CRT D204TRM CONSULTA CRT-D US MR DF4
MEDTRONIC, INC.
D204TRM
Not in Commercial Distribution

  • 00613994714701 ()


  • Cardiac resynchronization therapy implantable defibrillator

Protecta™ CRT-D - 00613994714619

CRT D334TRM PROTECTA CRT-D US MR DF4
MEDTRONIC, INC.
D334TRM
Not in Commercial Distribution

  • 00613994714619 ()


  • Cardiac resynchronization therapy implantable defibrillator

Protecta™ XT CRT-D - 00613994714589

CRT D314TRM PROTECTA XT CRT-D US MR DF4
MEDTRONIC, INC.
D314TRM
Not in Commercial Distribution

  • 00613994714589 ()


  • Cardiac resynchronization therapy implantable defibrillator

Consulta® CRT-D - 00613994987099

CRT D204TRM CONSULTA CRTD US MR DF4 BCP
MEDTRONIC, INC.
D204TRM
Not in Commercial Distribution

  • 00613994987099 ()


  • Cardiac resynchronization therapy implantable defibrillator

Protecta™ CRT-D - 00613994987037

CRT D334TRM PROTECTA CRTD US MR DF4 BCP
MEDTRONIC, INC.
D334TRM
Not in Commercial Distribution

  • 00613994987037 ()


  • Cardiac resynchronization therapy implantable defibrillator

Protecta™ XT CRT-D - 00613994987006

CRT D314TRM PROTECTA XT CRTD US DF4 BCP
MEDTRONIC, INC.
D314TRM
Not in Commercial Distribution

  • 00613994987006 ()


  • Cardiac resynchronization therapy implantable defibrillator

Wi-Fi™ - 05414734506830

Wi-Fi Card
ST. JUDE MEDICAL, INC.
EX3213
In Commercial Distribution

  • 05414734506830 ()
EX3213

  • Multiple active implantable device programmer

HeartSine Samaritan PAD 450P - 05060167129773

Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167129773 ()
450-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
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