FDA Registration
Active
🇺🇸 United States
Intact Gen2 System
Reg #: 2133810
·
FEI: 3000203066
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MINNETRONIX, INC.
- Registration Number
- 2133810
- FEI Number
- 3000203066
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1635 ENERGY PARK DR.
- City
- Saint Paul
- State
- MN
- ZIP
- 55108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152596
Owner / Operator
- Firm Name
- Minnetronix Medical, Inc.
- Operator Number
- 9033484
- Address
- 1635 ENERGY PARK DR., --
- City
- Saint Paul
- State
- MN
- Postal Code
- 55108
- Country
- US
- Correspondent
- Mary Stietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2017-11-22 |
Proprietary Names
Intact Gen2 System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)