FDA Registration
Active
🇺🇸 United States
PrimeStore MTM 3mL (82-9033-100-00)
Reg #: 3013046485
·
FEI: 3013046485
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIO2 MEDICAL PRODUCTS, INC.
- Registration Number
- 3013046485
- FEI Number
- 3013046485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2250 Riley Street
- City
- Auburn
- State
- AL
- ZIP
- 36832
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN170029
Owner / Operator
- Firm Name
- SiO2 Medical Products, Inc.
- Operator Number
- 10075054
- Address
- 2250 Riley Street
- City
- Auburn
- State
- AL
- Postal Code
- 36832
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2022-05-15 |
Proprietary Names
PrimeStore MTM 3mL (82-9033-100-00)
PrimeStore MTM 2mL (82-9028-100-00)
PrimeStore MTM 1.5mL (82-9026-100-00)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)