FDA device listing
BleedArrest ER,NexFoam,NexStat,NexStat/NexFoam
FDA device listing 1131340959 · Sotera Health LLC
Key facts
| Proprietary names | BleedArrest ER,NexFoam,NexStat,NexStat/NexFoam |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LYA, NHB, QSY |
| Device names | LYA - Splint, Intranasal Septal, NHB - Polymer, Ear, Nose And Throat, Synthetic, Absorbable, QSY - Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device class | Class I, Class II, Unclassified |
| Classification regulations (21 CFR) | 874.3620, 874.4780, ORCA1.QSY |
| Review panels | Ear, Nose, & Throat, General & Plastic Surgery |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1058584, 1061124, 1423662, 2029275 |
| FEI numbers | 1000219637, 1000306431, 1000512168, 3000215273 |
| 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