FDA device listing
Disposable MRI Kit with Check Valve (SQK-65VA),Disposable MRI Kit with Check Valve (SQK 65VS),Disposable MRI Tubing Set…
FDA device listing 1357014819 · Sotera Health LLC
Key facts
| Proprietary names | Disposable MRI Kit with Check Valve (SQK-65VA),Disposable MRI Kit with Check Valve (SQK 65VS),Disposable MRI Tubing Set (SIT-96V),Female to Female Adapter,Female-to-Female Luer Adapter (FFA-50),MEDRAD® Spectris Disposable MRI Kit with Check Valve (SQK 65VA),MEDRAD® Spectris Disposable MRI Kit with Check Valve (SQK 65VS),MEDRAD® Spectris Solaris 96 (244 cm) MRI Integral “T” with Check Valve for… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LNH |
| Device names | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | Sterigenics Radiation Technologies IN, Inc, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1058584, 1319639, 1526534, 3009504230 |
| FEI numbers | 1526534, 1000138054, 1000219637, 3009504230 |
| 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