FDA device listing
19GX1.5,BULK(NEDL-PRO DEVICE) **,BULK(NEDL-PRO S DEVICE) **,HYPODERMIC NEEDLE PRO 21G X 1-1/2 (OTSUKA) 800/CA Portex…
FDA device listing 1041048506 · Sotera Health LLC
Key facts
| Proprietary names | 19GX1.5,BULK(NEDL-PRO DEVICE) **,BULK(NEDL-PRO S DEVICE) **,HYPODERMIC NEEDLE PRO 21G X 1-1/2 (OTSUKA) 800/CA Portex Hypodermic Needle-Pro Device,HYPODERMIC NEEDLE PRO 21G X 2 (OTSUKA) 600/CA Portex Hypodermic Needle-Pro Device,Hypodermic Needle Pro 3mL LL Syringe & 21G X 1-1/2 ( Otsuka ) 400/CA Portex Hypodermic Needle-Pro Device,HYPODERMIC NEEDLE-PRO DEVICE WITH NEEDLE - 20G X 2" & 21G X 1"… |
|---|---|
| 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 U.S., LLC |
| Establishment registrations | 1319639 |
| FEI numbers | 1000138054 |
| 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