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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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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 NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece
The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece
The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions for use.
VECTURA GROUP PLC
FOX MOBILE Inhalation System (US)
In Commercial Distribution

  • 05056143200031 ()
  • 05056143200048 ()
08CD0010

  • Benchtop nebulizer, non-heated
The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
VECTURA GROUP PLC
FOX MOBILE Base Unit
In Commercial Distribution

  • 05056143200024 ()
  • 05056143202035 ()
08RS5000

  • Benchtop nebulizer, non-heated
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
In Commercial Distribution

  • 00628011941015 ()
101

  • Indirect flat panel x-ray detector
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