FDA device listing
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA device listing 1416301755 · STERIS Corporation
Key facts
| Owner/operator | STERIS Corporation |
|---|---|
| Owner/operator number | 1527821 |
| Product codes | LGW, QRB |
| Device names | LGW - Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, QRB - Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LGW, ORCA1.QRB |
| Review panels | Neurology |
| Registered establishments | Isomedix Operations, Inc. |
| Establishment registrations | 2030624 |
| FEI numbers | 3000206435 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database