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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No Description
HUGH STEEPER LIMITED
Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Standard- COAPT
In Commercial Distribution

  • 05056394327075 ()
EEH-L001LD-CO

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Standard
In Commercial Distribution

  • 05056394327068 ()
EEH-L001LD

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire DC Cased Electrode Cable
In Commercial Distribution

  • 05056394326313 ()
EE-CP-DC

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Battery Charger- Dual Bay- US
In Commercial Distribution

  • 05056394326061 ()
EE-CH-2US

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Battery Charger- Single Bay- US
In Commercial Distribution

  • 05056394326030 ()
EE-CH-1US

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Battery Car Charger-US
In Commercial Distribution

  • 05056394326009 ()
EE-CCH-US

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Bump Switch
In Commercial Distribution

  • 05056394325972 ()
EE-BS

  • Electrical elbow prosthesis
No Description
HUGH STEEPER LIMITED
Espire Battery
In Commercial Distribution

  • 05056394325484 ()
EE-BAT

  • Electrical elbow prosthesis
SFTWR 8870AAR01 SM2 STIM UPDATE W/MRI
MEDTRONIC, INC.
8870AAR01
In Commercial Distribution

  • 00643169342873 ()


  • Multiple active implantable device programmer
No Description
Synapse Biomedical, Inc.
20-0025
In Commercial Distribution

  • 00852184003519 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator
No Description
Synapse Biomedical, Inc.
20-0032
In Commercial Distribution

  • 00852184003243 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator
No Description
Synapse Biomedical, Inc.
20-0024
In Commercial Distribution

  • 00852184003236 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator
No Description
Synapse Biomedical, Inc.
23-0021
In Commercial Distribution

  • 00852184003212 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator
PROG 97745FA PAT THRPY MNGR FIXED ASSET
MEDTRONIC, INC.
97745FA
In Commercial Distribution

  • 00643169778061 ()


  • Multiple active implantable device programmer
PROG 8880T2 CLINICIAN TELEMMOD CTM2 US
MEDTRONIC, INC.
8880T2
In Commercial Distribution

  • 00643169778054 ()


  • Multiple active implantable device programmer
Patient Controller
ST. JUDE MEDICAL, INC.
3875
In Commercial Distribution

3875

  • Multiple active implantable device programmer
Clinician Programmer
ST. JUDE MEDICAL, INC.
3874
In Commercial Distribution

3874

  • Multiple active implantable device programmer
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Communication System
Thoratec Corporation
HMT1100-R
In Commercial Distribution

  • 05415067033758 ()
HMT1100-R

  • Multiple active implantable device programmer
Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer
SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer
Communication System
Thoratec Corporation
HMT1100
In Commercial Distribution

  • 05415067032058 ()
HMT1100

  • Multiple active implantable device programmer
Patient Care System (PCS)
ST. JUDE MEDICAL, INC.
2
In Commercial Distribution

  • 05415067031174 ()
MER3700

  • Multiple active implantable device programmer
Patient Programmer
ST. JUDE MEDICAL, INC.
Stimulation Temp Evaluation
In Commercial Distribution

  • 05415067028709 ()
3857

  • Multiple active implantable device programmer
Patient Programmer
ST. JUDE MEDICAL, INC.
3856-R
In Commercial Distribution

  • 05415067027627 ()
3856-R

  • Multiple active implantable device programmer
DRG Patient Manual and Magnet
ADVANCED NEUROMODULATION SYSTEMS, INC.
7884
In Commercial Distribution

  • 05415067027313 ()
7884

  • Multiple active implantable device programmer
Patient Manual and Magnet
ADVANCED NEUROMODULATION SYSTEMS, INC.
3884
In Commercial Distribution

  • 05415067023971 ()
3884

  • Multiple active implantable device programmer
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3875
In Commercial Distribution

  • 05415067023681 ()
3875

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3874
In Commercial Distribution

  • 05415067023674 ()
3874

  • Multiple active implantable device programmer
Patient Programmer
ST. JUDE MEDICAL, INC.
3853
In Commercial Distribution

  • 05415067021120 ()
3853

  • Multiple active implantable device programmer
Patient Programmer
ST. JUDE MEDICAL, INC.
3856
In Commercial Distribution

  • 05415067021113 ()
3856

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3834
In Commercial Distribution

  • 05415067018014 ()
3834

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3850
In Commercial Distribution

  • 05415067017123 ()
3850

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3834
In Commercial Distribution

  • 05415067016492 ()
3834

  • Multiple active implantable device programmer
Handheld Device
ST. JUDE MEDICAL, INC.
EX4000
In Commercial Distribution

  • 05414734503648 ()
EX4000

  • Multiple active implantable device programmer
Merlin Antenna
ST. JUDE MEDICAL, INC.
3638
In Commercial Distribution

  • 05414734502078 ()
3638

  • Multiple active implantable device programmer
Patient Care System (Merlin™ PCS)
ST. JUDE MEDICAL, INC.
3650
In Commercial Distribution

  • 05414734500661 ()
3650

  • Multiple active implantable device programmer
Patient Programmer
ST. JUDE MEDICAL, INC.
3852
In Commercial Distribution

  • 05414734405775 ()
3852

  • Multiple active implantable device programmer
PROG 8840 N'VISION PHYSCN HNDHLD RFRB US
MEDTRONIC, INC.
8840
In Commercial Distribution

  • 00643169866218 ()


  • Multiple active implantable device programmer
Model 3834
ST. JUDE MEDICAL, INC.
3834
In Commercial Distribution

  • 05414734405188 ()
3834

  • Multiple active implantable device programmer
Power Adapter, RP Model 3834
ST. JUDE MEDICAL, INC.
1622
In Commercial Distribution

  • 05414734405133 ()
1622

  • Multiple active implantable device programmer
Patient Programmer
ADVANCED NEUROMODULATION SYSTEMS, INC.
3851
In Commercial Distribution

  • 05414734402736 ()
3851

  • Multiple active implantable device programmer
No Description
ST. JUDE MEDICAL, INC.
3850
In Commercial Distribution

  • 05414734402729 ()
3850

  • Multiple active implantable device programmer
Communication Wand
ADVANCED NEUROMODULATION SYSTEMS, INC.
Communication Wand
In Commercial Distribution

  • 05414734400794 ()
1232

  • Multiple active implantable device programmer
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
Handheld Device
ST. JUDE MEDICAL, INC.
EX4001
In Commercial Distribution

  • 05414734510059 ()
EX4001

  • Multiple active implantable device programmer
Wi-Fi Card
ST. JUDE MEDICAL, INC.
EX3213
In Commercial Distribution

  • 05414734506830 ()
EX3213

  • Multiple active implantable device programmer
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