FDA Registration
Active
🇺🇸 United States
StatSeal Disc
Reg #: 1066421
·
FEI: 3003395204
·
Expires 2025
Products
1
Proprietary Names
8
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
- K130324
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 | 2013-11-05 |
Proprietary Names
StatSeal Disc
StatSeal Advanced Disc
StatSeal Advanced RAD Disc
StatSeal Advanced Plus Disc
StatSeal Extra Large Disc
StatSeal Medium Disc
StatSeal Large Disc
StatSeal Extra Small Disc
Establishment Types
Manufacture Medical Device