FDA Registration
Active
🇺🇸 United States
0847 Universal Plus
Reg #: 2134848
·
FEI: 3003007868
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GRANITE MICROSYSTEMS, INC.
- Registration Number
- 2134848
- FEI Number
- 3003007868
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10202 NORTH ENTERPRISE DR.
- City
- MEQUON
- State
- WI
- ZIP
- 53092
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233644
Owner / Operator
- Firm Name
- GRANITE MICROSYSTEMS, INC.
- Operator Number
- 9039266
- Address
- 10202 NORTH ENTERPRISE DR., --
- City
- Mequon
- State
- WI
- Postal Code
- 53092
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-11-21 |
Proprietary Names
0847 Universal Plus
0846 Universal Dual
0848 Universal Dual Plus
0845 Universal
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)