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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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Kerecis® Omega3 BURN - 05694310961110

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Mesh ratio 2:1 Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310961127 ()
  • 05694310961110 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202N21D0D

  • Collagen wound matrix dressing

Axiostat Gauze - 00860008768674

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

Axiostat Gauze - 00860008768650

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

Axiostat Gauze - 00860008768636

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 Gauze - 00860008768612

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 Gauze - 08600087686740

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

Axiostat Gauze - 08600087686504

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

Axiostat Gauze - 08600087686368

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 Gauze - 08600087686122

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

SiOxD Wound Matrix - 10850021883000

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body’s natural healing process.
Sioxmed, LLC
EDS-10058
In Commercial Distribution

  • 10850021883000 ()
  • 00850021883003 ()
EDS-10058

  • Synthetic wound matrix dressing
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