FDA device listing
11166/20,11170/20,17120/25,18880/20,4.67Custom MedLabel Pack - Pack Name:MEDICATION LABELS Revision 2,4.986Custom…
FDA device listing 1383313187 · Sotera Health LLC
Key facts
| Proprietary names | 11166/20,11170/20,17120/25,18880/20,4.67Custom MedLabel Pack - Pack Name:MEDICATION LABELS Revision 2,4.986Custom MedLabel Pack - Pack Name:Labels Revision 5,BNIML01/50,BTM217/50,BTR230/50,BWT507/50,Custom Medication Labels Revision 2,Custom MedLabel Pack Package name: OSUM025 VIR SPEC PROC Revision 3,Custom MedLabel Pack - Pack Name:215 Surgery,Custom Medlabel Pack - Pack Name:AAA Stents,Custom… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LYV |
| Device names | LYV - Label Or Tag, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1319639, 1420032, 1423662, 1526534, 1721676, 2029015, 2029275, 3004111573 |
| FEI numbers | 1420032, 1526534, 1721676, 1000138054, 1000160458, 1000306431, 3000215273, 3004111573 |
| 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