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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 Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
HEMOSTASIS, LLC
9550054
In Commercial Distribution

  • 00858439001545 ()
  • 00858439001538 ()

  • Weight: 2.5 Gram


  • Bone wax, synthetic
The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
HEMOSTASIS, LLC
9550034
In Commercial Distribution

  • 00858439001514 ()
  • 00858439001521 ()

  • Weight: 3.5 Gram


  • Bone wax, synthetic
SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
SYNEDGEN, INC.
8 oz
In Commercial Distribution

  • 00852181005301 ()

  • Total Volume: 8 Fluid Ounce


  • Non-antimicrobial wound irrigation solution, multiple solute
SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
SYNEDGEN, INC.
4oz
In Commercial Distribution

  • 00852181005295 ()


  • Non-antimicrobial wound irrigation solution, multiple solute
The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9130154
In Commercial Distribution

  • 00858439001989 ()
  • 00858439001972 ()

  • Weight: 1 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9130144
In Commercial Distribution

  • 00858439001439 ()
  • 00858439001446 ()

  • Weight: 3 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.
Epien Medical, Inc.
101-2002
Not in Commercial Distribution

  • 00860004740308 ()

  • Total Volume: 2 Milliliter


  • Dental mouthwash
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
7x10 cm Meshed
In Commercial Distribution

  • 05694310961103 ()
  • 05694310961097 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202N03D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
300 sq cm Meshed
In Commercial Distribution

  • 05694310961028 ()
  • 05694310961011 ()

  • Area/Surface Area: 300 Square centimeter
50202N23D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
250 sq cm Meshed
In Commercial Distribution

  • 05694310961004 ()
  • 05694310960991 ()

  • Area/Surface Area: 250 Square centimeter
50202N24D0D

  • Animal-derived wound matrix dressing
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