FDA Registration
Active
🇺🇸 United States
NeuroBlate System
Reg #: 3009970070
·
FEI: 3009970070
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- MONTERIS MEDICAL CORP
- Registration Number
- 3009970070
- FEI Number
- 3009970070
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 131 Cheshire Lane, Suite 100
- City
- Minnetonka
- State
- MN
- ZIP
- 55305
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240877
Owner / Operator
- Firm Name
- Monteris Medical Corp
- Operator Number
- 10042500
- Address
- 131 Cheshire Lane Suite 100
- City
- Minnetonka
- State
- MN
- Postal Code
- 55305
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-12-02 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-12-02 |
| Neurosurgical Laser With Mr Thermography | ONO | Class 2 | General, Plastic Surgery | No | 2024-12-02 |
Proprietary Names
NeuroBlate System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device