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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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
No Description
Multi Radiance Medical
MR4 LaserStim Emitter G
In Commercial Distribution

  • 00852556007213 ()
650-108G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ LaserStim Emitter
In Commercial Distribution

  • 00852556007138 ()
850-108

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 LaserStim Emitter
In Commercial Distribution

  • 00852556007039 ()
650-108

  • Musculoskeletal infrared phototherapy unit, non-wearable
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Long
In Commercial Distribution

  • 00840295405582 ()


  • Sequential venous compression system inflator
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Short
In Commercial Distribution

  • 00840295405568 ()


  • Sequential venous compression system inflator
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Regular
In Commercial Distribution

  • 00840295405575 ()


  • Sequential venous compression system inflator
No Description
Ulthera, Inc.
UT-1N Rev. H
In Commercial Distribution

  • 00840763100360 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-3 Rev. H
In Commercial Distribution

  • 00840763100353 ()


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

  • 00840763100346 ()


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

  • 00840763100339 ()


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

  • 00840763100322 ()


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

  • 00840763100315 ()


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

  • 00840763100070 ()


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

  • 00840763100063 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-3 Rev. G
In Commercial Distribution

  • 00840763100056 ()


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

  • 00840763100049 ()


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

  • 00840763100032 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1 Rev G
Not in Commercial Distribution

  • 00840763100025 ()


  • 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
No Description
Ulthera, Inc.
UT-4 Rev L
In Commercial Distribution

  • 00840763100889 ()


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

  • 00840763100865 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
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
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
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
GAS WARMER
Conmed Corporation
GS1012
Not in Commercial Distribution

  • 30845854045224 ()
  • 10845854045220 ()
GS1012

  • Insufflation gas conditioning system
Focused Ultrasound for tissue heat or mechanical cellular disruption
Jeisys Medical Inc.
LIPOcel
In Commercial Distribution

  • 08800020100009 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
AQUA CLEANSE COLON IRRIGATION DEVICE
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947163 ()


  • Colonic lavage unit
The Aquanet EC-2000 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
Prime Pacific Health Innovations Corporation
EC-2000
In Commercial Distribution

  • 07540198000114 ()
4310

  • Colonic lavage unit
The Aquanet APS-100 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
Prime Pacific Health Innovations Corporation
APS-100
In Commercial Distribution

  • 07540198000107 ()
4305

  • Colonic lavage 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
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
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