FDA device listing
ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP,ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH LOOP…
FDA device listing 1238964843 · Sotera Health LLC
Key facts
| Proprietary names | ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP,ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH LOOP TIP,ACCU-TEMP HIGH TEMPERATURE CAUTERY 2 IN SHAFT WITH FINE TIP,ACCU-TEMP HIGH TEMPERATURE CAUTERY 2 IN SHAFT WITH LOOP TIP,ACCU-TEMP HIGH TEMPERATURE CAUTERY VASECTOR ELONGATED FINE TIP,ACCU-TEMP INTERCHANGEABLE CAUTERY TIP SINGLE USE FINE TIP,ACCU-TEMP INTERCHANGEABLE CAUTERY… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HQP |
| Device names | HQP - Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.4115 |
| 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