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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High Flow Insufflation Tubing
DEROYAL INDUSTRIES, INC.
28-0210NS
In Commercial Distribution

  • 50749756255597 ()
  • 00749756255592 ()
28-0210NS

  • Insufflation gas conditioning tubing set
Filter
DEROYAL INDUSTRIES, INC.
17-9778
In Commercial Distribution

  • 50749756249107 ()
  • 00749756249102 ()
17-9778

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0209
In Commercial Distribution

  • 50749756158799 ()
  • 00749756158794 ()
28-0209

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0216NS
In Commercial Distribution

  • 50749756630318 ()
  • 00749756630313 ()
28-0216NS

  • Insufflation gas conditioning tubing set
Heated Hi-Flow Insufflation Tubing
DEROYAL INDUSTRIES, INC.
28-0212HNS
In Commercial Distribution

  • 50749756627516 ()
  • 00749756627511 ()
28-0212HNS

  • Insufflation gas conditioning tubing set
Heated Hi-Flow Insufflation Tubing
DEROYAL INDUSTRIES, INC.
28-0212H
In Commercial Distribution

  • 50749756627233 ()
  • 00749756627238 ()
28-0212H

  • Insufflation gas conditioning tubing set
Adapter, Stryker- Bulk
DEROYAL INDUSTRIES, INC.
28-0223B
In Commercial Distribution

  • 50749756800513 ()
  • 00749756800518 ()
28-0223B

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0207NS
In Commercial Distribution

  • 50749756031290 ()
  • 00749756031295 ()
28-0207NS

  • Insufflation gas conditioning tubing set
Quick Connect Adaptor
DEROYAL INDUSTRIES, INC.
28-0202
In Commercial Distribution

  • 00749756027946 ()
28-0202

  • Insufflation gas conditioning tubing set
Insufflation Filter
DEROYAL INDUSTRIES, INC.
28-0205NS
In Commercial Distribution

  • 50749756025398 ()
  • 00749756025393 ()
28-0205NS

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0201NS
In Commercial Distribution

  • 50749756024872 ()
  • 00749756024877 ()
28-0201NS

  • Insufflation gas conditioning tubing set
Insufflation Filter
DEROYAL INDUSTRIES, INC.
28-0203
In Commercial Distribution

  • 30749756024847 ()
  • 00749756024846 ()
  • 50749756024841 ()
28-0203

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0207
In Commercial Distribution

  • 50749756024582 ()
  • 00749756024587 ()
28-0207

  • Insufflation gas conditioning tubing set
Tubing,Insuf w/.1 Micr Filter Colored Tube
DEROYAL INDUSTRIES, INC.
V28-0201
In Commercial Distribution

  • 30749756024410 ()
  • 00749756024419 ()
  • 50749756024414 ()
V28-0201

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0201
In Commercial Distribution

  • 30749756024335 ()
  • 00749756024334 ()
  • 50749756024339 ()
28-0201

  • Insufflation gas conditioning tubing set
Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Push-On Fitting,Non-Sterile_100ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model C-2000-NS
In Commercial Distribution

  • 26931918189564 ()
  • 16931918189567 ()
  • 06931918189560 ()


  • Insufflation gas conditioning tubing set
Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Quick-Connect Fitting,NS_100ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model C-2005-NS
In Commercial Distribution

  • 26931918178872 ()
  • 16931918178875 ()
  • 06931918178878 ()


  • Insufflation gas conditioning tubing set
Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Push-On Fitting,Sterile_25ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model C-2003-ST
In Commercial Distribution

  • 26931918163762 ()
  • 16931918163765 ()


  • Insufflation gas conditioning tubing set
Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Push-On Fitting,Non-Sterile_100ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model C-2003-NS
In Commercial Distribution

  • 26931918155699 ()
  • 16931918155692 ()
  • 06931918155695 ()


  • Insufflation gas conditioning tubing set
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
MIGUN LIFE CO., LTD
HY7000UM
In Commercial Distribution

  • B556HY7000UM0 ()


  • Freestanding electric massager
  • Musculoskeletal infrared phototherapy unit, non-wearable
  • Traction table, line-powered
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
KBL GmbH
R11-s-2848r1-1188i1 UP 12
In Commercial Distribution

  • 04260489020425 ()


  • Red/infrared light phototherapy unit
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
Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/20)
Carefusion Corporation
26405-001
Not in Commercial Distribution

  • 70846446005907 ()
26405-001

  • Inspiratory/expiratory limb respiratory tubing, reusable
  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/10)
Carefusion Corporation
26404-001
Not in Commercial Distribution

  • 70846446005891 ()
26404-001

  • Respiratory gas heating wire, adult
  • Ventilator breathing circuit, single-use
  • Inspiratory/expiratory limb respiratory tubing, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U530
In Commercial Distribution

  • 00855913001848 ()
U530

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U502
In Commercial Distribution

  • 00855913001824 ()
U502

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U501
In Commercial Distribution

  • 00855913001817 ()
U501

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
AQUA CLEANSE COLON IRRIGATION DEVICE
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947163 ()


  • Colonic lavage unit
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
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
GAS WARMER
Conmed Corporation
GS1012
Not in Commercial Distribution

  • 30845854045224 ()
  • 10845854045220 ()
GS1012

  • Insufflation gas conditioning system
No Description
Ulthera, Inc.
UT-3 Rev N
In Commercial Distribution

  • 00840763100858 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-2 Rev O
In Commercial Distribution

  • 00840763100841 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1N Rev N
In Commercial Distribution

  • 00840763100834 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UH-2 DS 2.0 Rev A
In Commercial Distribution

  • 00840763101152 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UC-1 Control Unit (PRIME) Rev. A
In Commercial Distribution

  • 00840763101145 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4N Rev L
In Commercial Distribution

  • 00840763100896 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
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