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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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
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
7 m Extension Tubing
STRYKER CORPORATION
0703-045-003
In Commercial Distribution

  • 07613327504125 ()
0703-045-003

  • Surgical plume evacuation system
Grounding Cable
STRYKER CORPORATION
0703-045-002
In Commercial Distribution

  • 07613327504118 ()
0703-045-002

  • Surgical plume evacuation system
SafeAir Compact Smoke Evacuator
STRYKER CORPORATION
0703-045-000
In Commercial Distribution

  • 07613327466249 ()
0703-045-000

  • 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
ExtendEVAC Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-00M702NS
In Commercial Distribution

  • 50749756874361 ()
  • 00749756874366 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-000702NS
In Commercial Distribution

  • 50749756874354 ()
  • 00749756874359 ()


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

  • 50749756874330 ()
  • 00749756874335 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000722NS
In Commercial Distribution

  • 50749756872589 ()
  • 00749756872584 ()


  • Surgical plume evacuation system
Universal Smoke Evac Attachment
DEROYAL INDUSTRIES, INC.
88-003590NS
In Commercial Distribution

  • 50749756884056 ()
  • 00749756884051 ()


  • Surgical plume evacuation system
Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-000601NS
In Commercial Distribution

  • 50749756877003 ()
  • 00749756877008 ()


  • Surgical plume evacuation system
Universal Smoke Evac Attachment
DEROYAL INDUSTRIES, INC.
88-000600NS
In Commercial Distribution

  • 00749756876995 ()
88-000600NS

  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000723NS
In Commercial Distribution

  • 50749756876143 ()
  • 00749756876148 ()


  • Surgical plume evacuation system
Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system
Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • 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 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
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
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation
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
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution

  • 00195278794772 ()
5953035

  • Stationary gamma camera system
  • Full-body CT system
870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system
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