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 Class Implantable

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

  • 00814105020548 ()


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

  • 00814105020524 ()


  • 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: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • 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
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
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 220vac motor
ACUDERM, INC.
EVAC IE-2
In Commercial Distribution

  • 10814105020446 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 110vac motor
ACUDERM, INC.
EVAC IE-1
In Commercial Distribution

  • 10814105020439 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac II, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IIW
In Commercial Distribution

  • 10814105020422 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac IE, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IEW
In Commercial Distribution

  • 10814105020415 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-II
In Commercial Distribution

  • 10814105020408 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac IE unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-IE
In Commercial Distribution

  • 10814105020392 ()


  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Navigation Tools Software
In Commercial Distribution

  • 07290114064545 ()
407-000024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EEG Recording Kit
In Commercial Distribution

  • 27290016450853 ()
750-02A011-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063863 ()
NOW-020025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG HeadBox Kit
In Commercial Distribution

  • 27290114063214 ()
750-020013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECOG HeadBox Kit
In Commercial Distribution

  • 27290114063207 ()
750-020016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114063191 ()
NOW-DFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063184 ()
NOW-DF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114062484 ()
750-020025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage Kit
In Commercial Distribution

  • 27290114062477 ()
750-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage KIT
In Commercial Distribution

  • 27290114062453 ()
750-020024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis Neuro Omega Drive Headstage KIT
In Commercial Distribution

  • 27290114062439 ()
750-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114062422 ()
NOW-020070-00

  • Depth electrode
60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system
SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system
SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system
PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

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

  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system
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