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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 OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000418 ()
  • 00870053000414 ()
  • 50870053000419 ()
1104

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000043 ()
  • 00870053000049 ()
  • 50870053000044 ()
1093

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000013 ()
  • 00870053000018 ()
1089

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HairCheck-DT (PCP) is an ELISA test kit used for qualitative detection of phencyclidine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Quest Diagnostics
K042726
Not in Commercial Distribution

  • 00868586000254 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
No Description
Sonoma Pharmaceuticals, Inc.
85024
In Commercial Distribution

  • 20868489000287 ()
  • 00868489000283 ()

  • Total Volume: 80 Milliliter
85024

  • Eyelid solution
No Description
Sonoma Pharmaceuticals, Inc.
85023
In Commercial Distribution

  • 20868489000270 ()
  • 00868489000276 ()

  • Total Volume: 40 Milliliter
85023

  • Eyelid solution
No Description
Sonoma Pharmaceuticals, Inc.
84993
In Commercial Distribution

  • 20867784000183 ()
  • 00867784000189 ()

  • Total Volume: 59 Milliliter
84993

  • Non-antimicrobial wound irrigation solution, multiple solute
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
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
Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over manually selectable force settings.
Neuromechanical Innovations, L.L.C.
ProAdjuster Kidz
Not in Commercial Distribution

  • 00860011416494 ()


  • Joint/spinal manipulator, electronic
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