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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No Description
I.C. MEDICAL, INC.
ICM-000-0307
Not in Commercial Distribution

  • 00817688021469 ()
  • 00817688021452 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0014
In Commercial Distribution

  • 00817688021445 ()
  • 00817688021438 ()


  • Surgical plume evacuation system
UNIVERSAL BLUE™ RF Sensor
I.C. MEDICAL, INC.
ICM-000-0599
In Commercial Distribution

  • 00817688020363 ()
ICM-000-0599

  • Surgical plume evacuation system
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
TX NOZZLE STARTER KIT PACK, EVAC HOSE 9"" 5/PER BAG
ACUDERM, INC.
TXPACK-1
In Commercial Distribution

  • 00814105021668 ()


  • Surgical plume evacuation system
Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop
ACUDERM, INC.
CTFEET
In Commercial Distribution

  • 00814105020586 ()


  • Surgical plume evacuation system
Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel
ACUDERM, INC.
DUALCART
In Commercial Distribution

  • 00814105020562 ()


  • Surgical plume evacuation system
Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
ACUDERM, INC.
PFTSW
In Commercial Distribution

  • 00814105020548 ()


  • Surgical plume evacuation system
Hose connector used to connect TX Pack or LTX Pack to hose
ACUDERM, INC.
HOSECON
In Commercial Distribution

  • 00814105020524 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • Surgical plume evacuation system
Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator
ACUDERM, INC.
CMB
In Commercial Distribution

  • 00814105020579 ()


  • Surgical plume evacuation system
Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
ACUDERM, INC.
EWMB
In Commercial Distribution

  • 00814105020555 ()


  • Surgical plume evacuation system
Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use with lasers.
ACUDERM, INC.
ARM
In Commercial Distribution

  • 00814105020531 ()


  • Surgical plume evacuation system
6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke.
ACUDERM, INC.
M1-FILTER
In Commercial Distribution

  • 00814105020470 ()


  • Surgical plume evacuation system
Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906151
In Commercial Distribution

  • 00814716020357 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906150
In Commercial Distribution

  • 00814716020340 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906750
In Commercial Distribution

  • 00814716020074 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906760
In Commercial Distribution

  • 00814716020067 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906500
In Commercial Distribution

  • 00814716020050 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation System (120 VAC)
Coopersurgical, Inc.
DM53502
In Commercial Distribution

  • 00888937019940 ()


  • Surgical plume evacuation system
LEEP System 1000® Smoke Evacuation System (110 VAC)
Coopersurgical, Inc.
6080-2
In Commercial Distribution

  • 00888937014440 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation (120 VAC)
Coopersurgical, Inc.
53502
In Commercial Distribution

  • 00888937014327 ()


  • Surgical plume evacuation system
Biovac Smoke Evacuator (120 VAC)
Coopersurgical, Inc.
909070
In Commercial Distribution

  • 00888937013986 ()


  • Surgical plume evacuation system
Smoke Evacuator 110V
Covidien LP
SE3690ZD
In Commercial Distribution

  • 10884521134140 ()


  • Surgical plume evacuation system
Unit filtration cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00088
In Commercial Distribution

  • 00872320005702 ()


  • Surgical plume evacuation system
Replacement small square inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00086
In Commercial Distribution

  • 00872320005603 ()


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

  • 00872320005450 ()
  • 00872320005504 ()


  • 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
Unit suction cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00089
In Commercial Distribution

  • 00872320005719 ()


  • Surgical plume evacuation system
Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00087
In Commercial Distribution

  • 00872320005696 ()


  • 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
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
EVACUATOR, SAFTEVAC, 110 VOLT
DERMATOLOGIC LAB AND SUPPLY, INC.
EV-I
In Commercial Distribution

  • 00609960001302 ()
EV-I

  • Surgical plume evacuation system
Smoke Evacuator Unit and one filter pack, 220 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
EV/2
In Commercial Distribution

  • 00609960000664 ()
EV/2

  • Surgical plume evacuation system
Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
EV
In Commercial Distribution

  • 00609960000657 ()
EV

  • Surgical plume evacuation system
Smoke Evacuator Unit and one FIL2 filter pack, 220 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
SA-1A2
In Commercial Distribution

  • 00609960000527 ()
SA-1A2

  • Surgical plume evacuation system
Smoke Evacuator Unit and one FIL2 filter pack, 110 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
SA-1A
In Commercial Distribution

  • 00609960000510 ()
SA-1A

  • Surgical plume evacuation system
No Description
Hydrafacial LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • 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
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
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
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