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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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Dryz™ BLU Unit-Dose Gingival Retraction Paste Sample (Contains; 3-Capsules)
PARKELL, INC.
S188UD
Not in Commercial Distribution

  • 20810000525144 ()
  • 00810000525140 ()
S188UD

  • Gingival retraction cord, non-medicated
DryZ® Blu Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
PARKELL, INC.
S192SP
In Commercial Distribution

  • 00810000525386 ()
S192SP

  • Gingival retraction cord, non-medicated
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 10ct
In Commercial Distribution

  • 00370275850502 ()


  • General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services.
Forward Science Technologies LLC
BioStom 25ct
In Commercial Distribution

  • 00370275850250 ()


  • General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 1ct
In Commercial Distribution

  • 00370275850106 ()


  • General oral wound dressing, non-animal-derived
Hemoban® Gel Complete Package
DENTSPLY INTERNATIONAL INC.
675130
In Commercial Distribution

  • D0026751101 ()
675110

  • Gingival retraction solution
ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOCl) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt. The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
V3BIO SDN. BHD.
ES1300W
In Commercial Distribution

  • 09551012610318 ()

  • Total Volume: 30 Milliliter
ES1300W

  • Antimicrobial wound irrigation solution
ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOCl) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt. The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
V3BIO SDN. BHD.
ES4400W
In Commercial Distribution

  • 09551012610295 ()

  • Total Volume: 250 Milliliter
ES4400W

  • Antimicrobial wound irrigation solution
ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOCl) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt. The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
V3BIO SDN. BHD.
ES5100W
In Commercial Distribution

  • 09551012610059 ()

  • Total Volume: 500 Milliliter
ES5100W

  • Antimicrobial wound irrigation solution
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