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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GAS WARMER
Conmed Corporation
GS1012
Not in Commercial Distribution

  • 30845854045224 ()
  • 10845854045220 ()
GS1012

  • Insufflation gas conditioning system
Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a wall fixed, non-portable machine.
TRANSCENDENCIAS COMERCIALES SL
HC-2000 Classic
In Commercial Distribution

  • B482HC2000C1 ()
  • B482HC2000C0 ()
HC-2000 Classic

  • Colonic lavage unit
Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a non-portable, wall-fixed machine.
TRANSCENDENCIAS COMERCIALES SL
HC-1 Classic
In Commercial Distribution

  • B482HC1C1 ()
  • B482HC1C0 ()
HC-1 Classic

  • Colonic lavage unit
Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a portable machine.
TRANSCENDENCIAS COMERCIALES SL
HC-1
In Commercial Distribution

  • B482HC11 ()
  • B482HC10 ()
HC-1

  • Colonic lavage unit
Focused Ultrasound for tissue heat or mechanical cellular disruption
Jeisys Medical Inc.
LIPOcel
In Commercial Distribution

  • 08800020100009 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40608
In Commercial Distribution

  • 10680651406085 ()
MCK2-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40589
In Commercial Distribution

  • 10680651405897 ()
MCK3-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(04-50/06-50)
In Commercial Distribution

  • 08806383557351 ()
4007-2075

  • Endodontic obturation system
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Beyes Dental Canada Inc
GP2003
In Commercial Distribution

  • 00837699001021 ()


  • Endodontic obturation system handpiece, heat conducting
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Beyes Dental Canada Inc
GP2003
In Commercial Distribution

  • 00990010302211 ()
GPRO P1

  • Endodontic obturation system handpiece, heat conducting
Keyless, precise, open-guided surgery kit, designed to allow for more accurate, efficient, and safe surgery with minimal error and drill heating.
Shinhung MST Co., Ltd.
CDW
In Commercial Distribution

  • 08806343921185 ()


  • Fixture/appliance dental drill bit, reusable
Tecotherm NEO cooling system
INSPIRATION HEALTHCARE LIMITED
NEO
In Commercial Distribution

  • 05060206921221 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arm Warming Sleeve Large
Avacore Technologies, Inc.
WU-200L
In Commercial Distribution

  • 00851137008014 ()
  • 10851137008011 ()
WU-200L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Warm UP Control Unit
Avacore Technologies, Inc.
WU-20
In Commercial Distribution

  • 00851137008007 ()
WU-20

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
STRYKER CORPORATION
8001
In Commercial Distribution

  • 07613327277555 ()
8001-000-001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Patient warming and cooling device
Gentherm Medical, LLC
233
In Commercial Distribution

  • 10613031871074 ()

  • Weight: 59.5 Kilogram
  • Weight: 131 Pound
  • Height: 95.3 Centimeter
  • Height: 37.5 Inch
  • Depth: 43.2 Centimeter
  • Depth: 17.0 Inch
  • Width: 43.2 Centimeter
  • Width: 17.0 Inch
87107

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Thermal Regulating System
Gentherm Medical, LLC
233
In Commercial Distribution

  • 10613031861075 ()

  • Weight: 59.5 Kilogram
  • Weight: 131 Pound
  • Height: 95.3 Centimeter
  • Depth: 43.2 Centimeter
  • Width: 43.2 Centimeter
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86107

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
Gentherm Medical, LLC
25-01
In Commercial Distribution

  • 10613031860009 ()

  • Weight: 131 Pound
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Surface Warming & Cooling System
ADROIT MEDICAL SYSTEMS, INC.
A3
In Commercial Distribution

  • 10615089310208 ()
3102-0001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
Tec Com Medizintechnik GmbH
NEO
In Commercial Distribution

  • 04260647540314 ()
8289830

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fluid Delivery Lines
Medivance, Inc.
73407L
In Commercial Distribution

  • 00801741080548 ()
73407L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000 Control Panel Screen Protector
Medivance, Inc.
75300
In Commercial Distribution

  • 00801741080470 ()
75300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Cleaning Solution
Medivance, Inc.
73905
In Commercial Distribution

  • 00801741080401 ()
73905

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Philips
Medivance, Inc.
73556
In Commercial Distribution

  • 00801741080388 ()
73556

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE
Medivance, Inc.
73555
In Commercial Distribution

  • 00801741080371 ()
73555

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Rusch
Medivance, Inc.
73554
In Commercial Distribution

  • 00801741080364 ()
73554

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector
Medivance, Inc.
73553
In Commercial Distribution

  • 00801741080357 ()
73553

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector
Medivance, Inc.
73552
In Commercial Distribution

  • 00801741080340 ()
73552

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Bard
Medivance, Inc.
73503
In Commercial Distribution

  • 00801741080302 ()
73503

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line
Medivance, Inc.
73490
In Commercial Distribution

  • 00801741080289 ()
73490

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Power Cord
Medivance, Inc.
73300
In Commercial Distribution

  • 00801741080258 ()
73300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Drain Tube
Medivance, Inc.
71900
In Commercial Distribution

  • 00801741080203 ()
71900

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fill Tube
Medivance, Inc.
71800
In Commercial Distribution

  • 00801741080197 ()
71800

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Shunt Line
Medivance, Inc.
70904
In Commercial Distribution

  • 00801741080173 ()
70904

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000
Medivance, Inc.
50000000L
In Commercial Distribution

  • 00801741080159 ()
50000000L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
ARCTIC SUN 6000 115V B PWR LNR
Medivance, Inc.
60000000L
In Commercial Distribution

  • 00801741161520 ()
60000000L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
ARCTIC SUN 6000 115V B PWR
Medivance, Inc.
60000000
In Commercial Distribution

  • 00801741161513 ()
60000000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Simulator
Medivance, Inc.
77700
In Commercial Distribution

  • 00801741080531 ()
77700

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Service Kit Model 5000
Medivance, Inc.
77100
In Commercial Distribution

  • 00801741080487 ()
77100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
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