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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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Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL Enhanced is indicated to be used for: The acute treatment of migraine with or without aura in patients 18 years of age or older. The preventative treatment of episodic migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY DUAL Enhanced
In Commercial Distribution

  • 05425018850273 ()
10601

  • Craniofacial analgesia electrical stimulator
The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.
Cefaly Technology SPRL
Prevent
In Commercial Distribution

10230

  • Craniofacial analgesia electrical stimulator
The Cefaly® Dual device is indicated for: - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Cefaly Technology SPRL
Dual
In Commercial Distribution

  • 05425018850259 ()
10505

  • Craniofacial analgesia electrical stimulator
The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.
Cefaly Technology SPRL
Acute
In Commercial Distribution

  • 05425018850242 ()
10405

  • Craniofacial analgesia electrical stimulator
Set Cefaly® : - Instruction manual - Cefaly® device - Cefaly® electrode - Storage box - Power adapter + cable
Cefaly Technology SPRL
10205
In Commercial Distribution

  • 05425018850129 ()


  • Craniofacial analgesia electrical stimulator
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
MEDICALGORITHMICS S A
P5HP-AA-ADS
In Commercial Distribution

  • 05903021560124 ()


  • Electrocardiographic ambulatory recorder
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8816C
Not in Commercial Distribution

  • 16436200289883 ()
  • 06436200289886 ()
  • 26436200289880 ()


  • Infrared patient thermometer, skin
LED MINOR PROCEDURE LIGHT
SKYTRON LLC
AURORA ASTRO
In Commercial Distribution

  • 10841736110536 ()


  • Transportable medical equipment stand, non-powered
  • Operating room light system
Tandem Mount with optional surgical or exam lighting.
SKYTRON LLC
Ergon 3
In Commercial Distribution

  • 10841736100896 ()
330 Series

  • General utility supply system, ceiling-mounted
  • Fixed examination/treatment room light
Central Tandem Mount with Lightweight Arm with optional surgical or exam lighting. .
SKYTRON LLC
Ergon 3
In Commercial Distribution

  • 10841736100889 ()
320 Series

  • General utility supply system, ceiling-mounted
  • Operating room light system
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