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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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
Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
Cefaly Technology SPRL
11302
In Commercial Distribution

  • 05425018850181 ()
  • 05425018850310 ()


  • Craniofacial analgesia electrical stimulator
CEFALY Enhanced Electrode Kit .3 electrodes
Cefaly Technology SPRL
11301
In Commercial Distribution

  • 05425018850174 ()
  • 05425018850303 ()


  • Craniofacial analgesia electrical stimulator
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 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 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
Kit 3 Electrodes Blue Gel for Cefaly II
Cefaly Technology SPRL
11202
In Commercial Distribution

  • 05425018850150 ()
  • 05425018850181 ()


  • Craniofacial analgesia electrical stimulator
Kit 3 electrodes for Cefaly II
Cefaly Technology SPRL
11201
In Commercial Distribution

  • 05425018850143 ()
  • 05425018850174 ()


  • 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
Kit 3 electrodes Blue Gel for Cefaly I
Cefaly Technology SPRL
11106
In Commercial Distribution

  • 05425018850105 ()
  • 05425018850204 ()


  • Craniofacial analgesia electrical stimulator
Kit 3 electrodes for Cefaly I
Cefaly Technology SPRL
11101
In Commercial Distribution

  • 05425018850044 ()
  • 05425018850198 ()


  • Craniofacial analgesia electrical stimulator
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS XD-BCB2
In Commercial Distribution

  • 25425017505840 ()
  • 05425017505846 ()
  • 15425017505843 ()


  • IVF oocyte aspiration needle, single-use
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS FD
In Commercial Distribution

  • 25425017503228 ()
  • 05425017503224 ()
  • 15425017503221 ()


  • IVF oocyte aspiration needle, single-use
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS C2
In Commercial Distribution

  • 25425017503044 ()
  • 05425017503040 ()
  • 15425017503047 ()


  • IVF oocyte aspiration needle, single-use
Intrauterine insemination cannula
Gynetics Medical Products NV
#4220 Plus
In Commercial Distribution

  • 15425017502088 ()
  • 05425017502081 ()
  • 25425017502085 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4502 B Seminor Flexible
In Commercial Distribution

  • 25425017502061 ()
  • 05425017502067 ()
  • 15425017502064 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4502 A Seminor Rigid
In Commercial Distribution

  • 25425017502054 ()
  • 05425017502050 ()
  • 15425017502057 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4225 Smooze Long
In Commercial Distribution

  • 25425017502047 ()
  • 05425017502043 ()
  • 15425017502040 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4225 Smooze Medium
In Commercial Distribution

  • 25425017502030 ()
  • 05425017502036 ()
  • 15425017502033 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4225 Smooze
In Commercial Distribution

  • 25425017502023 ()
  • 05425017502029 ()
  • 15425017502026 ()


  • Assisted reproduction transfer catheter/set
Intra uterine Artificial Insemination
Gynetics Medical Products NV
#4220 IUI Memo
In Commercial Distribution

  • 25425017502016 ()
  • 05425017502012 ()
  • 15425017502019 ()

  • Length: 206 Millimeter


  • Assisted reproduction transfer catheter/set
Intra uterine Artificial Insemination
Gynetics Medical Products NV
#4220 IUI
In Commercial Distribution

  • 25425017502009 ()
  • 05425017502005 ()
  • 15425017502002 ()

  • Length: 206 Millimeter


  • Assisted reproduction transfer catheter/set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#4000 The Tulip Memo
In Commercial Distribution

  • 25425017501415 ()
  • 05425017501411 ()
  • 15425017501418 ()

  • Total Volume: 0.21 Milliliter


  • Assisted reproduction catheter set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#4000 The Tulip
In Commercial Distribution

  • 25425017501316 ()
  • 05425017501312 ()
  • 15425017501319 ()

  • Total Volume: 0.21 Milliliter


  • Assisted reproduction catheter set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#2000 Semtrac W-180
In Commercial Distribution

  • 25425017501101 ()
  • 05425017501107 ()
  • 15425017501104 ()

  • Total Volume: 0.23 Milliliter


  • Assisted reproduction catheter set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#2000 Semtrac Set 5
In Commercial Distribution

  • 25425017501088 ()
  • 05425017501084 ()
  • 15425017501081 ()

  • Total Volume: 0.22 Milliliter


  • Assisted reproduction catheter set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#2000 Semtrac Set 4.2
In Commercial Distribution

  • 25425017501071 ()
  • 05425017501077 ()
  • 15425017501074 ()

  • Total Volume: 0.23 Milliliter


  • Assisted reproduction catheter set
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Gynetics Medical Products NV
#4219 Emtrac Set
In Commercial Distribution

  • 05425017501053 ()
  • 25425017501057 ()
  • 15425017501050 ()

  • Total Volume: 0.20 Milliliter


  • Assisted reproduction catheter set
The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
Gynetics Medical Products NV
#9164
In Commercial Distribution

  • 05425017500377 ()
  • 15425017500374 ()
  • 75425017500376 ()

  • Outer Diameter: 2.93 Millimeter
  • Length: 262 Millimeter


  • Endometrial biopsy kit
Endometrial curette
Gynetics Medical Products NV
#5164 Echosampler
In Commercial Distribution

  • 25425017500036 ()
  • 05425017500032 ()
  • 15425017500039 ()

  • Outer Diameter: 2.93 Millimeter
  • Length: 262 Millimeter


  • Endometrial biopsy kit
A colourless, odourless gel in a plastic tube with tamper evident seal and screw-top.
Lifestream Pharma
Oral Moisturizing Gel 15ml
In Commercial Distribution

  • 05425005127517 ()
  • 05425005127524 ()


  • Oropharyngeal mucosa protection material
TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit, Thin
Materialise NV
SD980.113
In Commercial Distribution

  • 05420060381133 ()
SD980.113

  • Custom-made cranial bone prosthesis
TRUMATCH Midface/Mandible - Titanium 3D Printed Orbital kit, without planning
Materialise NV
SD980.111
In Commercial Distribution

  • 05420060381119 ()
SD980.111

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Midface/Mandible - Titanium 3D Printed Orbital kit
Materialise NV
SD980.110
In Commercial Distribution

  • 05420060381102 ()


  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH TI Implant - Mandible - large
Materialise NV
SD980.109
In Commercial Distribution

  • 05420060381096 ()
SD980.109

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH TI Implant - Mandible - medium
Materialise NV
SD980.108
In Commercial Distribution

  • 05420060381089 ()
SD980.108

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH TI Implant - Mandible -small
Materialise NV
SD980.107
In Commercial Distribution

  • 05420060381072 ()
SD980.107

  • Craniofacial fixation plate kit, non-bioabsorbable
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