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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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STERILE Lead Tunnelers - 00852184003113

No Description
Synapse Biomedical, Inc.
21-0007-99
In Commercial Distribution

  • 00852184003113 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Site Start-up Kit - 00852184003083

No Description
Synapse Biomedical, Inc.
20-0039
In Commercial Distribution

  • 00852184003083 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, ALS CE - 00852184003076

No Description
Synapse Biomedical, Inc.
20-0064
In Commercial Distribution

  • 00852184003076 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, CE 2 EPG - 00852184003069

No Description
Synapse Biomedical, Inc.
20-0063
In Commercial Distribution

  • 00852184003069 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Patient Kit, 1 EPG - 00852184003052

No Description
Synapse Biomedical, Inc.
20-0046
In Commercial Distribution

  • 00852184003052 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS Patient Kit - 00852184003045

No Description
Synapse Biomedical, Inc.
20-0036
In Commercial Distribution

  • 00852184003045 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Kit, HDE - 00852184003038

No Description
Synapse Biomedical, Inc.
20-0028
In Commercial Distribution

  • 00852184003038 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit, ALS CE - 00852184003021

No Description
Synapse Biomedical, Inc.
20-0031
In Commercial Distribution

  • 00852184003021 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit - 00852184003014

No Description
Synapse Biomedical, Inc.
20-0030
In Commercial Distribution

  • 00852184003014 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx Diaphragm Pacing System - 00852184003007

No Description
Synapse Biomedical, Inc.
20-0035
In Commercial Distribution

  • 00852184003007 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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