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
Microbial Nucleic Acid Storage And Stabilization Device QBD

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)