FDA device listing
12 mm & Stapler Cannula Seal - 470380,SHEATH, DISPOSABLE, STAPLER, IS3000/IS4000, BOX OF 10 - 410370-03,SHEATH…
FDA device listing 1635294360 · Sotera Health LLC
Key facts
| Proprietary names | 12 mm & Stapler Cannula Seal - 470380,SHEATH, DISPOSABLE, STAPLER, IS3000/IS4000, BOX OF 10 - 410370-03,SHEATH, DISPOSABLE, STAPLER, IS3000/IS4000, BOX OF 10 - 410370-04,Si Stapler Sheath - 410370,Xi Conductive Reducer - 470381,Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07),Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09),Xi Seal (12mm & Stapler) - 470380,Xi Stapler 45 Reload (Blue)… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GDW, NAY |
| Device names | GDW - Staple, Implantable, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 878.4750 |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | Sterigenics Costa Rica S.R.L., Sterigenics EO Canada, Inc., Sterigenics S. de R.L. de C.V., Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1721686, 2022435, 2029015, 2029275, 9611665, 9616517, 3004111573, 3010432890 |
| FEI numbers | 1721686, 2022435, 1000160458, 1000306431, 3002807095, 3003117688, 3004111573, 3010432890 |
| 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