FDA device listing
20 GA PASSIVE ASPIRATOR ERASER,ERASER,20 GA. 135 DEG. CVD.,W/ACTIVE ASPIR.,ERASER,20 GA.,150 DEG CVD W/ACTIVE…
FDA device listing 1518814756 · Sotera Health LLC
Key facts
| Proprietary names | 20 GA PASSIVE ASPIRATOR ERASER,ERASER,20 GA. 135 DEG. CVD.,W/ACTIVE ASPIR.,ERASER,20 GA.,150 DEG CVD W/ACTIVE ASPIR.,ERASER,20GA SUCTION ASPIRATION,WET-FIELD ERASER 20 GA ACTIVE ASPIRATOR STRAIGHT,WET-FIELD ERASER 20 GA BLUNT TIP 135,WET-FIELD ERASER 20 GA PASSIVE ASPIRATOR STRAIGHT |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HQR |
| Device names | HQR - Apparatus, Cautery, Radiofrequency, Ac-Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.4100 |
| Review panels | Ophthalmic |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1319639 |
| FEI numbers | 1000138054 |
| 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