FDA device listing
200CS01,200CS05,200CS10,200CS30,201CS01,201CS10,201CS20,202CS01,202CS20,209CS20,212CS01,212CS05,212CS20,218CS20,222CS01…
FDA device listing 1303086738 · Sotera Health LLC
Key facts
| Proprietary names | 200CS01,200CS05,200CS10,200CS30,201CS01,201CS10,201CS20,202CS01,202CS20,209CS20,212CS01,212CS05,212CS20,218CS20,222CS01,222CS10,223CS01,223CS20,224CS01,224CS20,229CS01,BIOASSAY DISH, LOW PROFILE PS,CD177S01,CD178S01,CD179S01,COPH1,COPH10,COP-MIN,COP-NED,COPS1,COPS10,COPTS-01,COPTS-10,COPTS10ZL,COPTS-5,CST-H1,CST-H10,CST-NED,CST-S1,CST-S10,CT50-H1,CT50-S1,CT50-S10,HLH1ST,HLNEDLT,HLNEDST,HLS10LT,HLS… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Sterigenics Italy SpA, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1036836, 1061124, 1423662, 1526534, 2029275, 3004111573, 3010407203 |
| FEI numbers | 1036836, 1526534, 1000306431, 1000512168, 3000215273, 3004111573, 3010407203 |
| 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