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™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The 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

  • 50870053000358 ()
  • 00870053000353 ()
1114

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandage controls bleeding. The OneStop™ Bandage 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

  • 20870053000333 ()
  • 00870053000339 ()
  • 50870053000334 ()
1105

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The 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

  • 00870053000322 ()
  • 20870053000326 ()
  • 50870053000327 ()
1102

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000310 ()
  • 00870053000315 ()
1101

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000297 ()
  • 00870053000292 ()
1030

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

  • 50870053000136 ()
  • 00870053000131 ()
1090

  • Chitosan haemostatic agent, professional, non-bioabsorbable
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
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
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.
AG300
In Commercial Distribution

  • 00860008768612 ()


  • 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
PATCH,KYTOMATRIX,HEMOSTATIC,2,IN,X
MEDLINE INDUSTRIES, INC.
KYTO2020
In Commercial Distribution

  • 20193489141907 ()
  • 30193489141904 ()
  • 10193489141900 ()
KYTO2020

  • Chitosan haemostatic agent, professional, non-bioabsorbable
PATCH,KYTOMATRIX,HEMOSTATIC,1.5,INX1.5IN
MEDLINE INDUSTRIES, INC.
KYTO1515
In Commercial Distribution

  • 30193489141898 ()
  • 20193489141891 ()
  • 10193489141894 ()
KYTO1515

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
Aerosol and Liquid Packaging, Inc.
1
In Commercial Distribution

  • 00850021825102 ()
  • 00850021825058 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210615
In Commercial Distribution

  • 00858439001910 ()
  • 00858439001903 ()

  • Width: 0.8 Inch
  • Length: 2.3 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210614
In Commercial Distribution

  • 00858439001880 ()
  • 00858439001897 ()

  • Width: 0.7 Inch
  • Length: 1.7 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
HEMOSTASIS, LLC
9210223
Not in Commercial Distribution

  • 00858439001705 ()
  • 00858439001699 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • 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.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG4010
Not in Commercial Distribution

  • 08600087686740 ()


  • 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.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG1010
Not in Commercial Distribution

  • 08600087686504 ()


  • 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.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG150
Not in Commercial Distribution

  • 08600087686368 ()


  • 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.
AXIO BIOSOLUTIONS PRIVATE LIMITED
V35
Not in Commercial Distribution

  • 08600087686290 ()


  • 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.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG300
Not in Commercial Distribution

  • 08600087686122 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot EMS Rolled Gauze
TELEFLEX INCORPORATED
IPN928799
In Commercial Distribution

  • 20841495150375 ()
  • 10841495150378 ()
475

  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot Interventional, N/Clamshell, N/Tegaderm, Multi-Lang, 10X
TELEFLEX INCORPORATED
IPN928795
In Commercial Distribution

  • 20841495150337 ()
  • 10841495150330 ()
  • 30841495150334 ()
467Z

  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot Combat Gauze XL
TELEFLEX INCORPORATED
IPN928793
In Commercial Distribution

  • 20841495150313 ()
  • 10841495150316 ()
345

  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot Combat Gauze TraumaPad
TELEFLEX INCORPORATED
IPN928788
In Commercial Distribution

  • 20841495150269 ()
  • 10841495150262 ()
210

  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot Interventional Pre-Slit w/ Tegaderm
TELEFLEX INCORPORATED
IPN928786
In Commercial Distribution

  • 30841495150242 ()
  • 20841495150245 ()
  • 10841495150248 ()
188

  • Chitosan haemostatic agent, professional, non-bioabsorbable
QuikClot Interventional w/ Tegaderm
TELEFLEX INCORPORATED
IPN928785
In Commercial Distribution

  • 30841495150235 ()
  • 20841495150238 ()
  • 10841495150231 ()
183

  • Chitosan haemostatic agent, professional, non-bioabsorbable
CHITOSAM 100, 4IN X 4IN
SAM Medical Products
CT100-A-EN
In Commercial Distribution

  • 10822045000022 ()
  • 00822045000025 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
CHITOSAM 100, 3IN X 6FT
SAM Medical Products
CT100-C-EN
In Commercial Distribution

  • 10822045000008 ()
  • 00822045000001 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
CHITOSAM 100, 3IN X 4FT
SAM Medical Products
CT100-B-EN
In Commercial Distribution

  • 10822045000336 ()
  • 00822045000339 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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