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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Connector 22mm ID Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2145J
In Commercial Distribution

  • 10614559105399 ()
  • 30614559105393 ()
2145J

  • Surgical plume evacuation system
Mega Vac Connector Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2140J
In Commercial Distribution

  • 10614559105382 ()
  • 30614559105386 ()
2140J

  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • 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
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510ECBN
Not in Commercial Distribution

  • 30614559105119 ()
  • 10614559105115 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510BN
Not in Commercial Distribution

  • 30614559105102 ()
  • 10614559105108 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 2.1m
MEGADYNE MEDICAL PRODUCTS, INC.
2406J
In Commercial Distribution

  • 10614559104668 ()
  • 30614559104662 ()
2406J

  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 1m
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution

  • 10614559104651 ()
  • 30614559104655 ()
2403J

  • 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
Megadyne Smoke Evacuator
MEGADYNE MEDICAL PRODUCTS, INC.
MESE1
In Commercial Distribution

  • 10614559104545 ()
MESE1

  • Surgical plume evacuation system
E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()
MGEZLINK01

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

  • 10614559104439 ()


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

  • 10614559104422 ()
  • 30614559104426 ()


  • Surgical plume evacuation system
The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
STERIS CORPORATION
Smoke Evacuator Remote Switch Activator
Not in Commercial Distribution

  • 00724995150129 ()
QS0028

  • Surgical plume evacuation system
The HarmonyAIR Large Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
STERIS CORPORATION
Smoke Evacuation System
In Commercial Distribution

  • 00724995150044 ()
QS0020

  • Surgical plume evacuation system
The HarmonyAIR Small Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
STERIS CORPORATION
Smoke Evacuation System
In Commercial Distribution

  • 00724995150020 ()
QS0018

  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000725
In Commercial Distribution

  • 50749756314768 ()
  • 00749756314763 ()


  • Surgical plume evacuation system
Smoke EVAC Wand
DEROYAL INDUSTRIES, INC.
88-000700
In Commercial Distribution

  • 50749756305650 ()
  • 00749756305655 ()


  • Surgical plume evacuation system
Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter
Conmed Corporation
PX5-120
In Commercial Distribution

  • 10653405987550 ()
PX5-120

  • Surgical plume evacuation system
Laparoscopic Smoke Eliminator
Conmed Corporation
CD3900
Not in Commercial Distribution

  • 20653405045660 ()
  • 10653405045663 ()
  • 00653405045666 ()
CD3900

  • Surgical plume evacuation system
CABLE/STRAIN REL. BLACK
Conmed Corporation
711-7760
In Commercial Distribution

  • 10653405005179 ()
711-7760

  • Surgical plume evacuation system
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()


  • Surgical plume evacuation system
Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()


  • Surgical plume evacuation system
Smoke Attachment
Covidien LP
E3590
In Commercial Distribution

  • 20884524000296 ()
  • 10884524000299 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended for long procedures of up to 1 hour duration
ACUDERM, INC.
LTXPACK
In Commercial Distribution

  • 10814105020507 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration
ACUDERM, INC.
TXPACK
In Commercial Distribution

  • 10814105020491 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or 220vac motor
ACUDERM, INC.
EVAC II-2
In Commercial Distribution

  • 10814105020460 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor
ACUDERM, INC.
EVAC II-1
In Commercial Distribution

  • 10814105020453 ()


  • Surgical plume evacuation system
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