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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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Mini Vac - 10614559104439

Mini Vac Surgical Smoke Evacuator 220v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV220
Not in Commercial Distribution

  • 10614559104439 ()


  • Surgical plume evacuation system

Mini Vac - 10614559104422

Mini Vac Surgical Smoke Evacuator 120v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV120
Not in Commercial Distribution

  • 10614559104422 ()
  • 30614559104426 ()


  • Surgical plume evacuation system

KODIAK PL TL GRAFT BLOCK - 00819824028691

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block

Optimal-G - 07290017844312

The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness

ReoAmbulator - 07290017844305

The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness

MediSourceNet, Inc - 00850034735139

WELF-5 : WelFit Adaptor for ESU Pencils and Hyfrecators, 15' hose (1pc)
Medisourcenet, Inc
WELF-5
In Commercial Distribution

  • 10850034735136 ()
  • 00850034735139 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735108

EXTL-5 : Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTL-5
In Commercial Distribution

  • 10850034735105 ()
  • 00850034735108 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735085

EXTL - Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTL
In Commercial Distribution

  • 10850034735082 ()
  • 00850034735085 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735061

REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGLI-5
In Commercial Distribution

  • 10850034735068 ()
  • 00850034735061 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735054

REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGLI
In Commercial Distribution

  • 10850034735051 ()
  • 00850034735054 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735030

KWV-LT : KwikVac Liquid Trap / 20pcs in one box
Medisourcenet, Inc
KWV-LT
In Commercial Distribution

  • 00850034735030 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735016

KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each
Medisourcenet, Inc
KWV-DT
In Commercial Distribution

  • 00850034735016 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735009

KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc)
Medisourcenet, Inc
KWV-M
In Commercial Distribution

  • 00850034735009 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735160

KWV-StarterKit, Smoke Evacuation starter Kit. Includes Smoke Evacaution unit, Filter and Detecto.
Medisourcenet, Inc
KWV-StarterKit
In Commercial Distribution

  • 00850034735160 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735122

WELF - WelFit Adaptor for ESU Pencils and Hyfrecators, 10' hose (1pc)
Medisourcenet, Inc
WELF
In Commercial Distribution

  • 10850034735129 ()
  • 00850034735122 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735115

EXTLI-5 : Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTLI-5
In Commercial Distribution

  • 10850034735112 ()
  • 00850034735115 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735092

EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTLI
In Commercial Distribution

  • 10850034735099 ()
  • 00850034735092 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735078

REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGL-5
In Commercial Distribution

  • 10850034735075 ()
  • 00850034735078 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735047

REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGL
In Commercial Distribution

  • 10850034735044 ()
  • 00850034735047 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735023

KWV-F : KwikVac Smoke Evacuation Filter / 1 each
Medisourcenet, Inc
KWV-F
In Commercial Distribution

  • 00850034735023 ()
  • 10850034735020 ()


  • Surgical plume evacuation system

NA - 08800042415952

Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block

NA - 08800048410296

TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block

NA - 08800048404127

Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block

NA - 08800048402215

Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block

MiE - Gamma Camera Systems - 04260484140074

The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system

MiE - Gamma Camera Systems - 04260484140043

The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system

ECAM-SCINTRON - 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system

LiteGait - 00850040235012

LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness

EVO sEEG Electrode - 00856895008627

54.5mm x 16 contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG5516-RF
In Commercial Distribution

  • 00856895008627 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008610

47.5mm x 14 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4814-RF
In Commercial Distribution

  • 00856895008610 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008603

40.5mm x 12 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4112-RF
In Commercial Distribution

  • 00856895008603 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008597

33.5mm x 10 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG3410-RF
In Commercial Distribution

  • 00856895008597 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008580

26.5mm x 8 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG2708-RF
In Commercial Distribution

  • 00856895008580 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

EVO sEEG Electrode - 00856895008573

16mm x 5 Contact sEEG Electrode - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG1605-RF
In Commercial Distribution

  • 00856895008573 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO Cable Assembly - 00856895008375

EVO Cable Assembly Only
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
EVO Cable Assembly
In Commercial Distribution

  • 00856895008375 ()
NEC1602

  • Cortical electrode
  • Depth electrode

EVO sEEG Electrode - 00856895008351

NeuroOne 35mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
35mm Anchor Bolt
In Commercial Distribution

  • 00856895008351 ()
NSEEG0035

  • Depth electrode

EVO sEEG Electrode - 00856895008344

NeuroOne 30mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
30mm Anchor Bolt
In Commercial Distribution

  • 00856895008344 ()
NSEEG0030

  • Depth electrode

EVO sEEG Electrode - 00856895008337

NeuroOne 25mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
25mm Anchor Bolt
In Commercial Distribution

  • 00856895008337 ()
NSEEG0025

  • Depth electrode

EVO sEEG Electrode - 00856895008320

NeuroOne 20mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
20mm Anchor Bolt
In Commercial Distribution

  • 00856895008320 ()
NSEEG0020

  • Depth electrode

EVO sEEG Electrode - 00856895008313

80mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
80mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008313 ()
NSEEG8016

  • Depth electrode
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