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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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Cytal® Burn Matrix, 5cm x 5cm
ACELL, INC.
BMM0505
In Commercial Distribution

  • 00386190001097 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter
BMM0505

  • Animal-derived wound matrix dressing
MPM Triple Helix Collagen Wound Drsg 7X7 Sterile. is an advance wound care device 100% bovine type 1 collagen. MPM collagen is a biogradable pad to absorbe exudate Package configuration: 1 dressing per SBS; 10 SBS per case
Mpm Medical, LLC
2
In Commercial Distribution

  • 00366977377775 ()
MP00377

  • Animal-derived wound matrix dressing
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 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 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
The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. 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
Microswitch
In Commercial Distribution

  • 00862290000319 ()


  • Cognitive assessment software
The Test of Variables of Attention (T.O.V.A.) USB Device is a USB-peripheral that precisely and accurate records and securely stores a subject's responses to the T.O.V.A. test. 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
USB Device
In Commercial Distribution

  • 00862290000302 ()


  • Cognitive assessment software
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
TENS PLUS INDUSTRIAL COMPANY
ED3930
In Commercial Distribution

  • 14897076720092 ()
ED3930

  • Analgesic transcutaneous electrical nerve stimulation system
Silver-sept® Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger.
ANACAPA TECHNOLOGIES, INC.
3015S
In Commercial Distribution

  • 00367180312157 ()
  • 00367180300154 ()

  • Weight: 43 Gram
3015S

  • Wound hydrogel dressing, antimicrobial
Silver-sept® Silver Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger.
ANACAPA TECHNOLOGIES, INC.
3003S
In Commercial Distribution

  • 00367180300031 ()
  • 00367180312034 ()

  • Weight: 86 Gram
3003S

  • Wound hydrogel dressing, antimicrobial
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