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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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Ora-GUARD - 00816161015131

Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00816161015131 ()


  • Removable dental occlusal splint, customizable

CARDINAL HEALTH - 00888499001353

Hydrogel Excellent viscosity Clean, greaseless formulation Indications: Use for partial to full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Caution: If condition worsens or does not improve within 10 to 14 days, consult a physician. For external use only. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Store at ambient temperature.
Cardinal Health 200, LLC
HG1OZ
In Commercial Distribution

  • 10888499001350 ()
  • 00888499001353 ()
HG1OZ

  • Wound hydrogel dressing, non-sterile

Picis Perioperative and Critical Care - 00851831007078

Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software

Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container - 00851383003238

Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
00323
In Commercial Distribution

  • 10851383003235 ()
  • 00851383003238 ()

  • Total Volume: 1 Liter
00323

  • Antimicrobial wound irrigation solution

Vashe Wound Solution 475 ml (16 fl oz) Instillation Container - 00851383003177

Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) size with an instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
00317
In Commercial Distribution

  • 10851383003174 ()
  • 00851383003177 ()

  • Total Volume: 475 Milliliter
00317

  • Antimicrobial wound irrigation solution

Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container - 00851383003160

Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz)) size with an instillation cap.
URGO MEDICAL NORTH AMERICA, LLC
00316
In Commercial Distribution

  • 10851383003167 ()
  • 00851383003160 ()

  • Total Volume: 250 Milliliter
00316

  • Antimicrobial wound irrigation solution

HSEU - 10304040151447

Intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative andoperative dentistry used with gingival retraction cord. It is also intended to facilitate the insertion of the cord into the sulcus.
HENRY SCHEIN, INC.
5702540
In Commercial Distribution

  • 20304040151444 ()
  • 10304040151447 ()
  • 00304040151440 ()
5702540

  • Gingival retraction solution

Vashe Wound Solution 1 L (34 fl oz) Flip Top Container - 00851383003221

Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
00322
In Commercial Distribution

  • 10851383003228 ()
  • 00851383003221 ()

  • Total Volume: 1 Liter
00322

  • Antimicrobial wound irrigation solution

Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap - 00851383003139

Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz) size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
00313
In Commercial Distribution

  • 00851383003139 ()
  • 10851383003136 ()

  • Total Volume: 250 Milliliter
00313

  • Antimicrobial wound irrigation solution

Vashe Wound Solution 118 ml container - Flip Cap - 00851383003122

Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 118 ml (4 fl. oz.) size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
00312
In Commercial Distribution

  • 10851383003129 ()
  • 00851383003122 ()

  • Total Volume: 118 Milliliter


  • Antimicrobial wound irrigation solution
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