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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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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

AngelMed Guardian EXD Model EXD-001 - 00850012625032

EXD-001 Kit (Latin-American Spanish)
Avertix Medical Inc.
0203-2100-002-C4#P16
In Commercial Distribution

  • 00850012625032 ()
0203-2100-002-C4#P16

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Model EXD-001 - 00850012625025

EXD-001 Kit
Avertix Medical Inc.
0203-2100-002#P16
In Commercial Distribution

  • 00850012625025 ()
0203-2100-002#P16

  • Implantable cardiac monitor programmer/transmitter/alarm

Imagio® - 00864802000459

Imagio Breast Imaging System Model 9100
Seno Medical Instruments, Inc.
9100
In Commercial Distribution

  • 00864802000459 ()
9100-000-02

  • Optoacoustic/ultrasound imaging system

BAROSTIM NEO - 00859144004470

BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
CVRX, INC.
1037
In Commercial Distribution

  • 00859144004470 ()
100063-222

  • Baroreceptor electrical stimulation system

BAROSTIM NEO - 00859144004463

BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
CVRX, INC.
1036
In Commercial Distribution

  • 00859144004463 ()
100063-212

  • Baroreceptor electrical stimulation system

BAROSTIM Lead Repair Kit - 00859144004456

Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004456 ()
100056-202

  • Baroreceptor electrical stimulation system

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
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