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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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Tap 4.5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039820356 ()
FA.IN.6045

  • Bone tap, reusable
neXus Sonicone Curette Tip Excel Kit
MISONIX, INC.
120-31-13C3
In Commercial Distribution

  • 00841626103580 ()
  • 00841626103597 ()


  • Wound therapy ultrasound system handpiece tip
neXus SonicOne® O.R. SonicVac & Tubeset
MISONIX, INC.
120-31-13C2
In Commercial Distribution

  • 00841626103405 ()
  • 00841626103108 ()


  • Wound therapy ultrasound system handpiece tip
neXus SonicOne® O.R. SonicVac & Tubeset
MISONIX, INC.
120-31-13X2
In Commercial Distribution

  • 00841626103412 ()
  • 00841626103115 ()


  • Wound therapy ultrasound system handpiece tip
neXus SonicOne® O.R. Hatched Probe & Tubeset
MISONIX, INC.
120-31-10X1
In Commercial Distribution

  • 00841626103399 ()
  • 00841626103092 ()


  • Wound therapy ultrasound system handpiece tip
neXus SonicOne® O.R. SonicVac & Tubeset
MISONIX, INC.
120-31-10R1
In Commercial Distribution

  • 00841626103382 ()
  • 00841626103085 ()


  • Wound therapy ultrasound system handpiece tip
Nylon Nightguard/Occlusal Appliance
SERENA SLEEP SOLUTIONS LLC
Nylon Nightguard/Occlusal Appliance
In Commercial Distribution

  • 00860005753086 ()


  • Mouthguard, reusable
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
90509
In Commercial Distribution

  • 00859290006151 ()
  • 10859290006158 ()
  • 20859290006155 ()
  • 30859290006152 ()
90000FG

  • Mouthguard, reusable
Grind No More Ready-to-wear Dental Guard 16 Dental Guards Up To 48 Uses
MEIJER, INC.
VBM736EC1
In Commercial Distribution

  • 00713733567404 ()
  • 30713733567405 ()
  • 10713733567401 ()
  • 20713733567408 ()


  • Mouthguard, reusable
Thermoplastic mouth guard - Case of 3
Grind Guard Technologies, L.L.C.
203
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000050 ()
203

  • Mouthguard, reusable
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