FDA device listing
SIT-96V,Spectra Solaris ® Tubing Set (SSIT-96VLD),Spectris Solaris 96 low pressure connector tube with…
FDA device listing 1333814929 · Sotera Health LLC
Key facts
| Proprietary names | SIT-96V,Spectra Solaris ® Tubing Set (SSIT-96VLD),Spectris Solaris 96 low pressure connector tube with T-connector,Spectris Solaris Qwik-Fit Syringe,Spectris Solaris® Syringe Kit (SQK-65S),Spectris Solaris® Syringe Kit (SQK-65VA),Spectris Solaris® Syringe Kit (SSQK-115),Spectris Solaris® Syringe Kit (SSQK 65/115vs),SSIT-96VLD |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | DXT |
| Device names | DXT - Injector And Syringe, Angiographic |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1650 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics Radiation Technologies IN, Inc, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1058584, 1526534, 3009504230 |
| FEI numbers | 1526534, 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