FDA Registration
Active
🇨🇷 Costa Rica
SPRINT Peripheral Nerve Stimulation (PNS) System
Reg #: 3023531666
·
FEI: 3023531666
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Nextern Costa Rica Ltd.
- Registration Number
- 3023531666
- FEI Number
- 3023531666
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Multitenant 2 Modulo 4.
- City
- Cartago
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K223306
Owner / Operator
- Firm Name
- Nextern Innovation, Inc
- Operator Number
- 10037078
- Address
- 10601 Fountains Drive
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- Caroline Byrd
US Agent
- Business Name
- NEXTERN INNOVATION, INC
- Contact Name
- Caroline Byrd
- Address
- 10601 Fountains Drive
- City
- Maple Grove
- State
- MN
- ZIP
- 55369
- Country
- US
- [email protected]
- Phone
- 651 2032100
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | Class 2 | Neurology | No | 2023-01-31 |
Proprietary Names
SPRINT Peripheral Nerve Stimulation (PNS) System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)