FDA device listing
ReActiv8 System
FDA device listing 1484070739 · GREATBATCH MEDICAL
Key facts
| Proprietary names | ReActiv8 System |
|---|---|
| Owner/operator | GREATBATCH MEDICAL |
| Owner/operator number | 9035261 |
| Product codes | QLK |
| Device names | QLK - Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QLK |
| Review panels | Neurology |
| Registered establishments | Centro de Construccion de Cardioestimuladores del Uruguay S.A. |
| Establishment registrations | 3010326622 |
| FEI numbers | 3010326622 |
| Establishment operations | Contract Manufacturer, 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