FDA Registration
Active
🇺🇸 United States
WoundSeal + Applicator
Reg #: 1066421
·
FEI: 3003395204
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOLIFE, LLC
- Registration Number
- 1066421
- FEI Number
- 3003395204
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8163 25th Ct E
- City
- SARASOTA
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080210
Owner / Operator
- Firm Name
- BIOLIFE, LLC
- Operator Number
- 9046506
- Address
- 8163 25th Court East, --
- City
- Sarasota
- State
- FL
- Postal Code
- 34243
- Country
- US
- Correspondent
- Bryan Martin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2009-04-07 |
Proprietary Names
WoundSeal + Applicator
StatSeal Advanced Powder
WoundSeal Powder
WoundSeal MD + Applicator
WoundSeal Rapid Response
StatSeal
Establishment Types
Manufacture Medical Device