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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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BAROSTIM Programmer - 00859144004449

Model 9010 Programmer System (US Commercial)
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004449 ()
100055-202

  • Baroreceptor electrical stimulation system

BAROSTIM NEO - 00859144004432

BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
CVRX, INC.
2102
In Commercial Distribution

  • 00859144004432 ()
100054-202

  • Baroreceptor electrical stimulation system

NA - 00859144004234

Accessory Kit
CVRX, INC.
5500
In Commercial Distribution

  • 00859144004234 ()
100033-301

  • Baroreceptor electrical stimulation system

NA - 00859144004227

Magnet
CVRX, INC.
5000
In Commercial Distribution

  • 00859144004227 ()
100034-301

  • Baroreceptor electrical stimulation system

Neo Legacy - 00859144004210

Neo Legacy Implantable Pulse Generator
CVRX, INC.
2100
In Commercial Distribution

  • 00859144004210 ()
100053-301

  • Baroreceptor electrical stimulation system

NA - 00859144004203

Carotid Sinus Lead Repair Kit
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004203 ()
100056-301

  • Baroreceptor electrical stimulation system

NA - 00859144004128

Programmer System
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004128 ()
100055-102

  • Baroreceptor electrical stimulation system

AngelMed Guardian Programmer Wand EXD Model EXD-001 - 00850012625070

PROG-003 Wand
Avertix Medical Inc.
0204-2100-067#P15
In Commercial Distribution

  • 00850012625070 ()
0204-2100-067#P15

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Lanyard - 00850012625056

EXD Lanyard
Avertix Medical Inc.
0203-2100-003
In Commercial Distribution

  • 00850012625056 ()
0203-2100-003

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Carrying Case - 00850012625049

EXD Carrying Case
Avertix Medical Inc.
0203-2100-004
In Commercial Distribution

  • 00850012625049 ()
0203-2100-004

  • Implantable cardiac monitor programmer/transmitter/alarm
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