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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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Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD) in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MA1500
In Commercial Distribution

  • 05070002841210 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MS1000
In Commercial Distribution

  • 05070002841203 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas
DMG AMERICA, LLC
61055
In Commercial Distribution

  • D033610551 ()
  • D033610550 ()

  • Weight: 28 Gram
003-61055

  • Dental restorative material varnish
ZenithDental Natural Cure Composite 1-14g base, 1-14g Catalyst with mixing pads and spatulas
DMG AMERICA, LLC
61050
In Commercial Distribution

  • D033610501 ()
  • D033610500 ()

  • Weight: 28 Gram
003-61050

  • Dental restorative material varnish
Neck Pads Black W/Bright Blue
HENRY SCHEIN, INC.
1069512
In Commercial Distribution

  • 00304040018477 ()
1069512

  • Orthodontic face bow
Neck Pads Black W/Denim Blue
HENRY SCHEIN, INC.
1067260
In Commercial Distribution

  • 00304040018453 ()
1067260

  • Orthodontic face bow
Neck Pads Black W/Purple
HENRY SCHEIN, INC.
1065647
In Commercial Distribution

  • 00304040018446 ()
1065647

  • Orthodontic face bow
Neck Pads Black W/Teal
HENRY SCHEIN, INC.
1063211
In Commercial Distribution

  • 00304040018422 ()
1063211

  • Orthodontic face bow
Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
NOVO NORDISK INC.
720006
In Commercial Distribution

  • 30301697200065 ()
  • 00301697200064 ()
720006

  • Percutaneous medicine administration kit, non-medicated, single-use
Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles and gauze pads.
ELI LILLY AND COMPANY
MC0002
In Commercial Distribution

  • 50300021151558 ()
  • 00300021151553 ()
MC0002001AM

  • Glucose monitoring system IVD, home-use
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