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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EvBNH-15 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-15
In Commercial Distribution

  • 20817325022983 ()
  • 10817325022986 ()
  • 00817325022989 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-10 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-10
In Commercial Distribution

  • 20817325022976 ()
  • 10817325022979 ()
  • 00817325022972 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH Push Button ESU Smoke Pencil - 2.5'' Stainless & Coated Blade, Holster, ESU Smoke Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBNH Push Button ESU Smoke Pencil
In Commercial Distribution

  • 20817325020767 ()
  • 10817325020760 ()
  • 00817325020763 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBH Push Button ESU Pencil - 2.5'' Stainless Blade, Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBH Push Button ESU Pencil
In Commercial Distribution

  • 00817325020756 ()
  • 10817325020753 ()
  • 20817325020750 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBN Push Button ESU Pencil - 2.5'' Stainless & Coated Blade, No Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBN Push Button ESU Pencil
In Commercial Distribution

  • 20817325020743 ()
  • 10817325020746 ()
  • 00817325020749 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvB Push Button ESU Pencil - 2.5'' Stainless Blade, No Holster, Smoke Pencil, 10'' Cable
MEDIMAX TECH INC.
EvB Push Button ESU Pencil
In Commercial Distribution

  • 20817325020736 ()
  • 10817325020739 ()
  • 00817325020732 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
Tube Adapter
MEGADYNE MEDICAL PRODUCTS, INC.
2151J
In Commercial Distribution

  • 10614559105733 ()
  • 30614559105737 ()
2151J

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1E
In Commercial Distribution

  • 10614559105672 ()
  • 30614559105676 ()
ME725M1E

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251E
In Commercial Distribution

  • 10614559105665 ()
  • 30614559105669 ()
ME7251E

  • Surgical plume evacuation system
Megadyne Smoke Evacuator RF Sensor
MEGADYNE MEDICAL PRODUCTS, INC.
2255J
In Commercial Distribution

  • 10614559104644 ()
  • 30614559104648 ()
  • 50614559104642 ()
2255J

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1C
In Commercial Distribution

  • 10614559105658 ()
  • 30614559105652 ()
ME725M1C

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251C
In Commercial Distribution

  • 10614559105641 ()
  • 30614559105645 ()
ME7251C

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2540J
In Commercial Distribution

  • 10614559105320 ()
  • 30614559105324 ()
  • 50614559105328 ()
2540J

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

  • 10614559104439 ()


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

  • 10850034735129 ()
  • 00850034735122 ()


  • Surgical plume evacuation system
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
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
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
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
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
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
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
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
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
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 Only
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
EVO Cable Assembly
In Commercial Distribution

  • 00856895008375 ()
NEC1602

  • Cortical electrode
  • Depth electrode
NeuroOne 35mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
35mm Anchor Bolt
In Commercial Distribution

  • 00856895008351 ()
NSEEG0035

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

  • 00856895008344 ()
NSEEG0030

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

  • 00856895008337 ()
NSEEG0025

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

  • 00856895008320 ()
NSEEG0020

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

  • 00856895008313 ()
NSEEG8016

  • Depth electrode
68.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
68.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008306 ()
NSEEG6916

  • Depth electrode
61.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
61.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008290 ()
NSEEG6216

  • Depth electrode
54.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
54.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008283 ()
NSEEG5516

  • Depth electrode
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
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1801
In Commercial Distribution

  • M7161111818010 ()
111-18-1801

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1601
In Commercial Distribution

  • M7161111816010 ()
111-18-1601

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1501
In Commercial Distribution

  • M7161111815010 ()
111-18-1501

  • Press-fit femoral stem prosthesis
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