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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Replacement primary cotton filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00046
In Commercial Distribution

  • 00872320005450 ()
  • 00872320005504 ()


  • Surgical plume evacuation system
Replacement inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00050
In Commercial Distribution

  • 00872320005498 ()


  • Surgical plume evacuation system
Replacement collection tube for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00049
In Commercial Distribution

  • 00872320005481 ()


  • Surgical plume evacuation system
Replacement charcoal filter cartridge for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00048
In Commercial Distribution

  • 00872320005474 ()


  • Surgical plume evacuation system
Replacement secondary fiberglass filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00047
In Commercial Distribution

  • 00872320005467 ()


  • Surgical plume evacuation system
Plume vacuum station to provide suction for removing plume, spray, and particulates generated during dental procedures.
CAO GROUP, INC.
005-00045
In Commercial Distribution

  • 00872320004958 ()


  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

  • 20845854053109 ()
ECVV220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
Not in Commercial Distribution

  • 20845854053093 ()
ECVV120

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220P1
Not in Commercial Distribution

  • 20845854081355 ()
VC220P1

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220
In Commercial Distribution

  • 20845854081324 ()
VC220

  • Surgical plume evacuation system
Smoke Attachment Extender
Covidien LP
E3595
In Commercial Distribution

  • 10884524001814 ()
  • 20884524001811 ()


  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
VC220NF
Not in Commercial Distribution

  • 20845854081348 ()
VC220NF

  • Surgical plume evacuation system
ViroSafe VisiClear Filter Smoke Evacuation Filter 3-port - 1/4 in (6.4mm), 3/8 in (9.5mm), and 7/8 in (22mm)
Conmed Corporation
VV220
In Commercial Distribution

  • 20845854081317 ()
VV220

  • Surgical plume evacuation system
PlumeSafe TURBO Surgical Smoke Evacuator 220V-240V 50/60 Hz
Conmed Corporation
PSWTURBO_AS/220
In Commercial Distribution

  • 20845854081195 ()
PSWTURBO_AS 220

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-230
In Commercial Distribution

  • 20653405059094 ()
  • 10653405059097 ()
60-8080-230

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-120
In Commercial Distribution

  • 20653405059087 ()
  • 10653405059080 ()
60-8080-120

  • Surgical plume evacuation system
Portable Cart for Smoke Evacuators
Buffalo Filter
ETC01
Not in Commercial Distribution

  • 00851136002396 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
PPS604
Not in Commercial Distribution

  • 00851136002044 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
VV120NF
Not in Commercial Distribution

  • 00851136002853 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with ViroVac Filter
Buffalo Filter
VV120
Not in Commercial Distribution

  • 00851136002815 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuation System
Buffalo Filter
SV3120V
Not in Commercial Distribution

  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system
Surgical Smoke Evacuator with Filter
Buffalo Filter
PSWTURBO AS
Not in Commercial Distribution

  • 00851136002419 ()


  • Surgical plume evacuation system
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD SERONO, INC.
U1222102
Not in Commercial Distribution

  • 04054839025860 ()


  • Empty self-injector, electronic
one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
EMD SERONO, INC.
U1222402
Not in Commercial Distribution

  • 04054839025792 ()


  • Empty self-injector, mechanical
No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
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
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use
EVO Cable Assembly Only
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
EVO Cable Assembly
In Commercial Distribution

  • 00856895008375 ()
NEC1602

  • Cortical electrode
  • Depth electrode
SPSTI-SL-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Swivel Type, Button, Holster, Insulated Blade, 5 meter Hose
MEDIMAX TECH INC.
SPSTI-SL5
In Commercial Distribution

  • 20817325023744 ()
  • 10817325023747 ()
  • 00817325023740 ()
  • 40817325023748 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPSTI-SL -EvaQMaxPen, Smoke Pencil, Telescopic, Swivel Type, Button, Holster, Insulated Blade, 3 meter Hose
MEDIMAX TECH INC.
SPSTI-SL
In Commercial Distribution

  • 20817325023737 ()
  • 10817325023730 ()
  • 00817325023733 ()
  • 30817325023734 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPST-SL-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Swivel type, Button, Holster, Non-Stick Blade, 5 meter Hose
MEDIMAX TECH INC.
SPST-SL5
In Commercial Distribution

  • 20817325023720 ()
  • 10817325023723 ()
  • 00817325023726 ()
  • 30817325023727 ()


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