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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HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000117 ()
  • 20870053000111 ()
  • 50870053000112 ()
1032

  • 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
Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Advamedica Inc.
SH1006
In Commercial Distribution

  • 00860012016648 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Advamedica Inc.
SH1004
In Commercial Distribution

  • 00860012016631 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Advamedica Inc.
SH1001
In Commercial Distribution

  • 00860012016624 ()


  • 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
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG4010
In Commercial Distribution

  • 00860008768674 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG1010
In Commercial Distribution

  • 00860008768650 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG150
In Commercial Distribution

  • 00860008768636 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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