FDA device listing
0290-530-000,0290-540-000,0290-647-000,0290-648-000,0290-740-200,0290-744-100,BUR 31151098E VISAO 1MM 98MM L 20DEG…
FDA device listing 1313341004 · Sotera Health LLC
Key facts
| Proprietary names | 0290-530-000,0290-540-000,0290-647-000,0290-648-000,0290-740-200,0290-744-100,BUR 31151098E VISAO 1MM 98MM L 20DEG SST,BUR 31151598E VISAO 1.5MM 98MM L 20D SST,BUR 31152090E VISAO 2MM 90MM L 20DG SST,BUR 31153090E VISAO CVD 3MM 90L 15DEG,BUR 31154090E VISAO CVD 4MM 90L 15DEG,BUR 311710115E VISAO 1MM 115MM L 20D SST,BUR 311715115E VISAO 1.5MM 115 L 20D SST,BUR 311720115E VISAO 2MM 115 L 20DG… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | EQJ |
| Device names | EQJ - Bur, Ear, Nose And Throat |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4140 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Sterigenics US LLC |
| Establishment registrations | 1058584, 1649518 |
| FEI numbers | 1000219637, 3001236277 |
| 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