hemostasisllc.comResolv Endoscopic Hemostat System
Hemostasis, LLC
HEMOSTASIS, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007225047 | 3007225047 | HEMOSTASIS, LLC | 1 | N | 2026-01-01 | 5000 Township Pkwy Saint Paul MN US 55110 |
| 3039667438 | 3039667438 | HEMOSTASIS BIOMEDICAL, LLC | 1 | N | 2026-01-01 | 5000 Township Pkwy Saint Paul MN US 55110 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00858439001279 | PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001309 | PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001330 | PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001361 | PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001385 | PosiSep C - PosiSep C devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001552 | BoneSeal 2x2.5 gram Ingot - 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. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001699 | ExcelArrest XT 2x2 Hemostatic Patch - ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches. | +1 651-855-1466 | customerservice@hemostasisllc.com |
| 00858439001774 | AeroClear - The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction. | +1 651-855-1466 | customerservice@hemostasisllc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 97704 | 1195920318 | K234131 | Resolv Endoscopic Hemostat System | QAU | 2024-07-26 |
| 97704 | 1120720721 | K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | EMX | 2022-11-14 |
| 97704 | 1511841770 | K142348 | OsteoSeal Bone Hemostat | MTJ | 2015-01-23 |
| 341793 | 1544071190 | K142348 | OsteoSeal Bone Hemostat | MTJ | 2015-01-23 |
| 97704 | 1035589517 | K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | QSY | 2012-11-15 |
| 97704 | 1644961321 | K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | LYA | 2013-03-27 |
| 97704 | 1299781117 | K120958 | POSISEP AND POSISEP X HEMOSTAT DRESSINGS | QSY | 2012-07-25 |
| 97704 | 1217873326 | K102459 | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE | QSY | 2010-12-03 |
| 97704 | 2054506250 | K072900 | EXCELARREST FOAM | QSY | 2007-10-26 |
| 97704 | 1101318145 | ||||
| 97704 | 1552418825 | ||||
| 97704 | 1893279711 | ||||
| 97704 | 2048141789 |
Product Codes Associated With Registrations#
PMN#
PosiSep X BAM Hemostat Dressing/Intranasal Splint
Hemostasis, LLC
PosiSep ME Fragmentable Ear Dressing
Hemostasis LLC
OsteoSeal Bone Hemostat
HEMOSTASIS, LLC
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
HEMOSTASIS, LLC
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
HEMOSTASIS, LLC
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
HEMOSTASIS, LLC
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
HEMOSTASIS, LLC
EXCELARREST FOAM
HEMOSTASIS, LLC
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
HEMOSTASIS, LLC
GUDID#
BoneSeal 2x2.5 gram Ingot - 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.
2019-05-06
ExcelArrest XT 2x2 Hemostatic Patch - ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
2020-11-20
AeroClear - The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction.
2020-11-30
PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep C - PosiSep C devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-02-20
PosiSep C² - PosiSep C² devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C² devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-02-20
PosiSep C 0.6 x 2.0 - PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-09-30
"PosiSep X2 0.8"" x 2.3""" - 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.
2021-05-03
"PosiSep X2 0.7"" x 1.7""" - 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.
2021-05-03
PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint - PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
NexStat 1gm - 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.
2021-05-03
PosiSep X2 0.8" x 2.3" - 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.
2021-05-03
NexStat 1gm - 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.
2021-05-03
NexPak - NexPak Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
2020-09-30
NexPak X - NexPak X Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak X Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
2020-09-30
ExcelArrest XT 2x2 Hemostatic Patch - ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
2020-11-20
NexStat Plus 2gm - The Hemostasis NexStat Plus 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.
2020-09-30
NexStat Plus 3gm - The hemostasis NexStat Plus 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.
2020-09-30
NexFoam - The Hemostasis NexFoam topical hemostat sponge 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.
2020-09-30
NexStat Plus 2gm - The Hemostasis NexStat Plus 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.
2020-09-30
NexStat Plus 3gm - The hemostasis NexStat Plus 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.
2020-09-30
NexStat - 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.
2020-09-30
NexFoam - The Hemostasis NexFoam topical hemostat sponge 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.
2020-09-30
NexPak - NexPak Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
2020-09-30
NexPak X - NexPak X Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak X Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
2020-09-30
PosiSep C 0.6 x 2.0 - PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-09-30
BleedArrest ER - BleedArrest ER Topical Hemostat Sponge
2020-02-20
PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint - PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
2020-02-20
PosiSep C - PosiSep C devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-02-20
PosiSep C² - PosiSep C² devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C² devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
2020-02-20
BleedArrest ER - BleedArrest ER Topical Hemostat Sponge
2020-02-20
BoneSeal 2.5 gram Ingot - 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.
2019-05-06
BoneSeal 3.5 gram Ingot - 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.
2019-05-06
BoneSeal 2.5 gram Ingot - 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.
2019-05-06