FDA device listing
Colombia OBI Commercial Sterilized
FDA device listing 1315751370 · LTS Device Technologies
Key facts
| Proprietary names | Colombia OBI Commercial Sterilized |
|---|---|
| Owner/operator | LTS Device Technologies |
| Owner/operator number | 10088332 |
| Product codes | QLF |
| Device names | QLF - On-Body Injector |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5860 |
| Review panels | General Hospital |
| Registered establishments | LTS DEVICE TECHNOLOGIES |
| Establishment registrations | 3027691164 |
| FEI numbers | 3027691164 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| 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