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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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Senza - 00813426020817

HFX iQ Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426020817 ()
PTA10043

  • Implantable electrical stimulation device management software

Altius Programming Application PC - 00810118490064

No Description
Neuros Medical, Inc.
FG-608-000
In Commercial Distribution

  • 00810118490064 ()


  • Implantable electrical stimulation device management software

Head Coil (Receive Only) - 00868029000391

No Description
VIEWRAY INCORPORATED
23820
In Commercial Distribution

  • 00868029000391 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging

ITREL® EZ ™ - 00673978933733

PROGRAMMER 7434A ITREL 3 PATIENT
MEDTRONIC, INC.
7434A
In Commercial Distribution

  • 00673978933733 ()


  • Multiple active implantable device programmer

SJM MRI Activator™ - 05414734510059

Handheld Device
ST. JUDE MEDICAL, INC.
EX4001
In Commercial Distribution

  • 05414734510059 ()
EX4001

  • Multiple active implantable device programmer

Wi-Fi™ - 05414734506830

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

  • 05414734506830 ()
EX3213

  • Multiple active implantable device programmer

SJM MRI Activator™ - 05414734503648

Handheld Device
ST. JUDE MEDICAL, INC.
EX4000
In Commercial Distribution

  • 05414734503648 ()
EX4000

  • Multiple active implantable device programmer

Merlin™ - 05414734502078

Merlin Antenna
ST. JUDE MEDICAL, INC.
3638
In Commercial Distribution

  • 05414734502078 ()
3638

  • Multiple active implantable device programmer

Merlin™ - 05414734500661

Patient Care System (Merlin™ PCS)
ST. JUDE MEDICAL, INC.
3650
In Commercial Distribution

  • 05414734500661 ()
3650

  • Multiple active implantable device programmer

NA - 05414734405775

Patient Programmer
ST. JUDE MEDICAL, INC.
3852
In Commercial Distribution

  • 05414734405775 ()
3852

  • Multiple active implantable device programmer
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