FDA device listing
Hypodermic Needle-Single Lumen K-Pack II Needles 29G and 30G Regular Wall,K-Pack II Needles 29G and 30G Regular Wall
FDA device listing 1592239197 · Sotera Health LLC
Key facts
| Proprietary names | Hypodermic Needle-Single Lumen K-Pack II Needles 29G and 30G Regular Wall,K-Pack II Needles 29G and 30G Regular Wall |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FMI |
| Device names | FMI - Needle, Hypodermic, Single Lumen |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5570 |
| Review panels | General Hospital |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL |
| Establishment registrations | 3005941719 |
| FEI numbers | 3002807111 |
| 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