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OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.

The Hemostasis OsteoSeal® 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, OsteoSeal® forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. OsteoSeal® is based upon known biodegradable polymeric chemistry that forms a ready-to-use bone hemostatic agent. OsteoSeal® Bone Hemostat consists of a dispersion of hydroxyapatite particles within a proprietary synthetic polylactic acid polymer. The material is virtually odorless, off-white in color and can be spread easily. OsteoSeal® is available in two forms: a bone hemostat ingot and a bone hemostat stick in an applicator. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone, while the applicator allows direct application of the bone hemostat to the bleeding area.

PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - · Separate tissue or structures compromised by surgical trauma; - · Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; - · Help control minimal bleeding following surgery or trauma; - · Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and - · Act as an adjunct to aid in the natural healing process PosiSep™ and PosiSep™ X are indicated for use as a nasal hemostat to treat epistaxis. PosiSep" and PosiSep" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellulose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep" X Hemostat Dressing/Intranasal Splint have the material composition as the currently market cleared Hemostasis PosiSep™ and PosiSep Topical Hemostat. The PosiSep " and PosiSep" X Hemostat Dressing /Intranasal Splint are used for topical wounds and placed in the nasal cavity after surgery or trauma for the treatment of bleeding and as a space occupying stent to separate sinus tissue and prevent adhesions between mucosal surfaces. The dressings quickly dehydrate blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. PosiSep™ and PosiSep™X are removed from the sight of application by natural excretion and routine flushing to eliminate the material from the nasal cavity and avoid the issues involved with physical removal of a non-fragmenting dressing.

NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The Hemostasis NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding. The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are identical to the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of polysaccharide hemostatic particles is being changed for the NexStat® Plus and NexFoam® Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as NexStat® and NexFoam®. The indications for use remain the same as NexStat® and NexFoam®

PosiSep " and PosiSep" X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSep"" and PosiSep"" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™X Hemostat Dressings are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellylose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep™ X Hemostat Dressings have the identical material composition as the currently market cleared Hemostasis ExcelArrest Topical Hemostat. The PosiSep " and PosiSep " X Hemostat Dressings are used for topical wounds. The dressings quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations.

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, · dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites. OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations,