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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47.5mm x 14 Contact sEEG Electrode kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
47.5mm x 14 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008276 ()
NSEEG4814

  • Depth electrode
40.5mm x 12 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
40.5mm x 12 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008269 ()
NSEEG4112

  • Depth electrode
33.5mm x 10 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
33.5mm x 10 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008252 ()
NSEEG3410

  • Depth electrode
26.5mm x 8 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
26.5mm x 8 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008245 ()
NSEEG2708

  • Depth electrode
EVO sEEG Electrode 16mm x 5 Contact Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
16mm x 5 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008238 ()
NSEEG1605

  • Depth electrode
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
Origin Instant Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81026-OD-EI
In Commercial Distribution

  • B77881026ODEI0 ()
81026-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81025-OD-EI
In Commercial Distribution

  • B77881025ODEI0 ()
81025-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
80902-OD-EI
In Commercial Distribution

  • B77880902ODEI0 ()
80902-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80600-OD-EI
In Commercial Distribution

  • B77880600ODEI0 ()
80600-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80510-OD-EI
In Commercial Distribution

  • B77880510ODEI0 ()
80510-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80502-OD-EI
In Commercial Distribution

  • B77880502ODEI0 ()
80502-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80409-OD-EI
In Commercial Distribution

  • B77880409ODEI0 ()
80409-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61147-3-OD
In Commercial Distribution

  • B778611473OD0 ()
61147-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC
ORIGIN DIAGNOSTICS LLC
61025-OD
In Commercial Distribution

  • B77861025OD0 ()
61025-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61013-3-OD
In Commercial Distribution

  • B778610133OD0 ()
61013-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
61007-OD-OTC
In Commercial Distribution

  • B77861007ODOTC0 ()
61007-OD-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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