FDA device listing
518-027 LLD ACCESSORY KIT,518-039 LLD E (3 pk),518-062 EZ (3 pk),518-067 LLD EZ SINGLE PACK
FDA device listing 1502566059 · Sotera Health LLC
Key facts
| Proprietary names | 518-027 LLD ACCESSORY KIT,518-039 LLD E (3 pk),518-062 EZ (3 pk),518-067 LLD EZ SINGLE PACK |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | DRB |
| Device names | DRB - Stylet, Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1380 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1721676 |
| FEI numbers | 1721676 |
| 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