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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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The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5071-0001-01
In Commercial Distribution

  • 00812101031179 ()
5071-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5071-0001-00
In Commercial Distribution

  • 00812101031162 ()
5071-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Knitted viscose mesh impregnated with 100% Manuka honey, 10cm x 10cm. Activon Tulle is a knitted viscose mesh primary dressing impregnated with 100% Medical Grade Manuka honey. Activon Tulle creates a moist healing environment and effectively eliminates wound odour. Activon Tulle® is ideally suited to debriding and de-sloughing shallow wounds or where the exudate levels have started to decrease.
BRIGHTWAKE LIMITED
CR4136
In Commercial Distribution

  • 05060031474152 ()
  • 05060031474145 ()
  • 05060031474169 ()

  • Length: 10 Centimeter
  • Width: 10 Centimeter


  • Wound-nonadherent dressing, permeable, antimicrobial
Knitted viscose mesh impregnated with 100% Manuka honey, 5cm x 5cm. Activon Tulle is a knitted viscose mesh primary dressing impregnated with 100% Medical Grade Manuka honey. Activon Tulle creates a moist healing environment and effectively eliminates wound odour. Activon Tulle® is ideally suited to debriding and de-sloughing shallow wounds or where the exudate levels have started to decrease.
BRIGHTWAKE LIMITED
CR4135
In Commercial Distribution

  • 05060031474107 ()
  • 05060031474114 ()
  • 05060031474121 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter


  • Wound-nonadherent dressing, permeable, antimicrobial
MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle.
Soleva Pharma LLC
Mucoadhesive Oral Wound Rinse
In Commercial Distribution

  • 00860013569907 ()


  • Wound hydrogel dressing, non-antimicrobial
  • General oral wound dressing, non-animal-derived
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX1010
In Commercial Distribution

  • 00860012016617 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
Advamedica Inc.
V35
In Commercial Distribution

  • 00860008768629 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
Advamedica Inc.
V55
In Commercial Distribution

  • 00860008768605 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
Advamedica Inc.
L88
In Commercial Distribution

  • 00860008768681 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX0510
In Commercial Distribution

  • 00860012016600 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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