FDA Registration
Active
🇺🇸 United States
Allograft MIS Delivery System / ViviGen MIS Delivery System
Reg #: 3009656988
·
FEI: 3009656988
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIPACK USA (LIMITED) LLC
- Registration Number
- 3009656988
- FEI Number
- 3009656988
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4255 S Pipkin Rd
- City
- Lakeland
- State
- FL
- ZIP
- 33811
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201338
Owner / Operator
- Firm Name
- SteriPack USA (Limited) LLC
- Operator Number
- 10044297
- Address
- 4255 South Pipkin Road
- City
- Lakeland
- State
- FL
- Postal Code
- 33811
- Country
- US
- Correspondent
- Marinela Cebic
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-04-08 |
Proprietary Names
Allograft MIS Delivery System / ViviGen MIS Delivery System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)