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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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Paired VNS - 10810041430042

Wireless Transmitter
Microtransponder
2000
In Commercial Distribution

  • 10810041430042 ()


  • Vagus nerve electrical stimulation system programmer

SEDASYS - 10705036010210

SEDASYS POWER SUPPLY UNIT
ETHICON ENDO-SURGERY, INC.
SEDPSU01
Not in Commercial Distribution

  • 10705036010210 ()
SEDPSU01

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 10705036010203

SEDASYS CONTROL UNIT
ETHICON ENDO-SURGERY, INC.
SEDPRU01
Not in Commercial Distribution

  • 10705036010203 ()
SEDPRU01

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 10705036010180

SEDASYS BEDSIDE MONITORING UNIT
ETHICON ENDO-SURGERY, INC.
SEDBMU01
Not in Commercial Distribution

  • 10705036010180 ()
SEDBMU01

  • Intraprocedural physiologic-monitoring sedation system

RHYTHMIA HDx™ - 08714729966326

Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system

Invenia - 00195278756237

Invenia ABUS Premium
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
ABUS R2.5 Premium
In Commercial Distribution

  • 00195278756237 ()
H5023S1-H5013S1

  • Breast ultrasound imaging system

VISITAG EXT PROCESSING UNIT ACCESS - 10846835018585

DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU SPARE - 10846835018578

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU - 10846835018554

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer

VISITAG SURPOINT External Processing Unit - 10846835017885

External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer
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