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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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No Description
Sonoma Pharmaceuticals, Inc.
P-E1174T00
In Commercial Distribution

  • 20860000883348 ()
  • 00860000883344 ()

  • Total Volume: 250 Milliliter
P-E1174T00

  • Non-antimicrobial wound irrigation solution, multiple solute
Blood Irradiator
RAD SOURCE TECHNOLOGIES, INC.
3400
In Commercial Distribution

  • 00860000737005 ()


  • In vitro ionizing-radiation blood irradiator
• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
HOME AIDE DIAGNOSTICS, INC.
6517
In Commercial Distribution

  • 10860000526514 ()
  • 00860000526517 ()


  • Skin cleaning wipe
Acupressure Bracelet
MUMEASE LLC
AB1
In Commercial Distribution

  • 00860000032803 ()


  • Acupressure wristband
Endodontic Lubricating Gel: Bulk Pack of 288 tubes
JORDCO INC
EG-BP
In Commercial Distribution

  • 00859611006716 ()

  • Total Volume: 1 Milliliter
EG-BP

  • Root canal cleaning solution
Dental Root Canal Lubricating and Cleanser gel, 12 tubes per pack
JORDCO INC
EG-s
In Commercial Distribution

  • 00859611006006 ()
  • 00859611006013 ()

  • Total Volume: 1.0 Milliliter
EG-S

  • Root canal cleaning solution
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
No Description
Interacoustics A/S
TRV
In Commercial Distribution

  • 05711117219098 ()


  • Canalith repositioning procedure chair, manual
No Description
Omeza, LLC
CM-720.001
Not in Commercial Distribution

  • 00859839007205 ()


  • Animal-derived wound matrix dressing
No Description
Omeza, LLC
CM-720.001
In Commercial Distribution

  • 00859839007212 ()
  • 00859839007014 ()
  • 00859839007038 ()


  • Animal-derived wound matrix dressing
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