FDA Registration
Active
🇺🇸 United States
5020 Console; 5025 Console
Reg #: 3014903258
·
FEI: 3014903258
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PIVOT - EDM
- Registration Number
- 3014903258
- FEI Number
- 3014903258
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12202 Cary Circle
- City
- La Vista
- State
- NE
- ZIP
- 68128
- Country
- US
Owner / Operator
- Firm Name
- Pivot - EDM
- Operator Number
- 10061153
- Address
- 12202 Cary Circle
- City
- La Vista
- State
- NE
- Postal Code
- 68128
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-12-01 |
Proprietary Names
5020 Console; 5025 Console
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)