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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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
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
InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
SCL Science Inc.
IS-H-01-20
In Commercial Distribution

  • 08800030700152 ()
  • 08800030700138 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
SCL Science Inc.
IS-H-01-10
In Commercial Distribution

  • 08800030700121 ()
  • 08800030700145 ()


  • 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
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