FDA device listing
Argyle Surgical Aspirator Tip,Bulb Yank: 42614,Catheter and Tip, Suction- Invuity Agilux Handheld Illuminator (H2I) Eigr…
FDA device listing 1464079985 · Sotera Health LLC
Key facts
| Proprietary names | Argyle Surgical Aspirator Tip,Bulb Yank: 42614,Catheter and Tip, Suction- Invuity Agilux Handheld Illuminator (H2I) Eigr Saber Waveguide, 12Fr,Ortho,Orthopedic Suction Set,Poole Tube: 8888509703,Poole Tube: 8888509737,Poole Tube: 88888509745,Repositional Chest Tube,SAFE-T-VAC: 30500,SAFE-T-VAC: 30520,SAFE-T-VAC: 30579,SAFE-T-VAC: 30620,SAFE-T-VAC: 30677,SAFE-T-VAC: 30688,SAFE-T-VAC… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JOL |
| Device names | JOL - Catheter And Tip, Suction |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6740 |
| Review panels | General Hospital |
| Registered establishments | Sterigenics Shanghai ETO Ltd., Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1061124, 1649518, 1721676, 2011171, 2029015, 2029275, 3002907620, 3004111573, 3007007790 |
| FEI numbers | 1721676, 2011171, 1000160458, 1000306431, 1000512168, 3001236277, 3002907620, 3004111573, 3007007790 |
| 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