FDA Registration
Active
🇦🇺 Australia
Evoke 12C Lead Extension Kit - 55cm
Reg #: 3021836309
·
FEI: 3021836309
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Saluda Medical Pty. Ltd.
- Registration Number
- 3021836309
- FEI Number
- 3021836309
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 Eden Park Drive
- City
- Macquarie Park New South Wales
- Country
- AU
Owner / Operator
- Firm Name
- Saluda Medical Pty Ltd
- Operator Number
- 10061701
- Address
- 5 Eden Park Drive
- City
- Macquarie Park
- State
- New South Wales
- Postal Code
- 2113
- Country
- AU
US Agent
- Business Name
- N/A
- Contact Name
- N/A
- Address
- N/A, N/A
- City
- N/A
- State
- NA
- ZIP
- N/A
- Country
- US
- N/A
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2019-11-14 |
Proprietary Names
Evoke 12C Lead Extension Kit - 55cm
Evoke Lead Adapter Kit
Evoke 12C Percutaneous Lead Kit - 60cm
Evoke Tunneling Tool
Evoke Spares Kit
Evoke Epidural Needle, 6.5"
Evoke 12C Percutaneous Lead Kit - 90cm
Evoke Intraoperative Cable Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device