FDA device listing
FLYTE TOGA, PEELAWAY, 2X,FLYTE TOGA PEELAWAY, 3X,FLYTE TOGA, PEELAWAY, L,FLYTE TOGA, PEELAWAY XL,FLYTE TOGA, PULLOVER…
FDA device listing 1492651751 · Sotera Health LLC
Key facts
| Proprietary names | FLYTE TOGA, PEELAWAY, 2X,FLYTE TOGA PEELAWAY, 3X,FLYTE TOGA, PEELAWAY, L,FLYTE TOGA, PEELAWAY XL,FLYTE TOGA, PULLOVER, 2X,FLYTE TOGA, PULLOVER, 3X,FLYTE TOGA, PULLOVER, L,FLYTE TOGA, ZIPPER, 2X,FLYTE TOGA, ZIPPER, 3X,FLYTE TOGA, ZIPPER, L,FLYTE TOGA, ZIPPER, XL |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FYA |
| Device names | FYA - Gown, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Costa Rica S.R.L., Sterigenics Germany GmbH, Sterigenics S. de R.L. de C.V., Sterigenics U.S., LLC |
| Establishment registrations | 1721686, 3002807090, 3008328679, 3010432890 |
| FEI numbers | 1721686, 3006003617, 3008328679, 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