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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 Blue Cable Set - 00852184003120

No Description
Synapse Biomedical, Inc.
21-0009-99
In Commercial Distribution

  • 00852184003120 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

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

BioRef-DC - 07290017249049

BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

INTERA - 00850014110147

Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable

Origin DAA Stem, High Offset - 09348215036454

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1803
In Commercial Distribution

  • 09348215036454 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036447

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1603
In Commercial Distribution

  • 09348215036447 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036430

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1503
In Commercial Distribution

  • 09348215036430 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1403
In Commercial Distribution

  • 09348215036423 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1303
In Commercial Distribution

  • 09348215036416 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036409

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1203
In Commercial Distribution

  • 09348215036409 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036393

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1103
In Commercial Distribution

  • 09348215036393 ()


  • Coated femoral stem prosthesis, modular
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