FDA Registration
Active
🇺🇸 United States
Otoscope
Reg #: 3014903258
·
FEI: 3014903258
·
Expires 2025
Products
1
Proprietary Names
2
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 |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2019-08-30 |
Proprietary Names
Otoscope
Otoscope - WiscMed Wispr
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)