FDA Registration
Active
🇺🇸 United States
HEMOSTASIS, LLC
Reg #: 3007225047
·
FEI: 3007225047
·
Expires 2026
Products
9
Proprietary Names
29
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- HEMOSTASIS, LLC
- Registration Number
- 3007225047
- FEI Number
- 3007225047
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5000 Township Pkwy
- City
- Saint Paul
- State
- MN
- ZIP
- 55110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122886
Owner / Operator
- Firm Name
- Hemostasis, LLC
- Operator Number
- 10023101
- Address
- 5000 Township Parkway
- City
- Saint Paul
- State
- MN
- Postal Code
- 55110
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2012-11-19 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2012-11-19 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2012-11-19 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2013-04-11 |
| Tube, Thorpe, Uncompensated | BYM | Class 1 | Anesthesiology | No | 2024-08-01 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2018-05-25 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2024-01-18 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2024-01-18 |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | Class 2 | General, Plastic Surgery | No | 2024-11-15 |
Proprietary Names
NexFoam Plus Topical Hemostat Sponge
NexStat Plus Topical Hemostat Powder
PosiSepX Hemostat Dressing/Intranasal Splint
PosiSep C Hemostat Dressing/Intranasal Splint
PosiSep Hemostat Dressing /Intranasl Splint
PosiSep C2 Hemostat Dressing/Intranasal Splint
PosiSep X2 Hemostat Dressing/Intranasal Splint
PosiSep X BioNocc
NexStat Topical Hemostat Powder
NexFoam Topical Hemostat Sponge
BleedArrest ER Topical Hemostat
GI Tank CO2 Flow Controller
GI House CO2 Flow Controller
PosiSep® X BAM
PosiSep D2
Vectra F
Vectra G
Vensure Balloon Dilation System
Vensure ET Balloon Dilation
Vensure Nav Balloon Dilation System
Vensure Light Balloon Dilation System
Resolv Endoscopic Hemostat System
PosiSep Hemostat Dressing
PosiSep X Hemostat Dressing
NexPak XL Intranasal Splint
NexPak X Intranasal Splint
PosiSep Intranasal Splint
PosiSep X Intranasal Splint
NexPak Intranasal Splint
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)