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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® - 05425018850334

Indications for Use: CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Prophylactic treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected Bundle VA
In Commercial Distribution

  • 05425018850334 ()
10811

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850297

CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected
In Commercial Distribution

  • 05425018850297 ()
10801

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850280

CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY Enhanced is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Enhanced
In Commercial Distribution

  • 05425018850280 ()
10701

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850273

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

Cefaly® - 05425018850266

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

Cefaly® - 05425018850259

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

Cefaly® - 05425018850242

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

Cefaly® - 05425018850129

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

NIRA Pro+ - 00850020752454

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

NIRA Precision Laser - 00850020752126

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
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