FDA Device Establishments · JSON-LD · Markdown
FEI 3021836309 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3021836309 |
|---|---|
| Owner / Operator | Saluda Medical Pty Ltd (#10061701) |
| Address | 5 Eden Park Drive, Macquarie Park New South Wales, 2113, AU |
| Mandatory US Agent | Saluda Medical Pty Ltd |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LGW |
| Proprietary names | Evoke Intraoperative Cable Kit; Evoke 12C Percutaneous Lead Kit - 90cm; Evoke Tunneling Tool; Evoke 12C Percutaneous Lead Kit - 60cm; Evoke 12C Lead Extension Kit - 55cm; Evoke Epidural Needle, 6.5"; Evoke Spares Kit; Evoke Lead Adapter Kit |
Source: openFDA. Public-domain (CC0).