FDA device listing
Gown, Surgical
FDA device listing 1263498098 · THI Total Healthcare Innovation GmbH
Key facts
| Owner/operator | THI Total Healthcare Innovation GmbH |
|---|---|
| Owner/operator number | 10089072 |
| Premarket submissions | K243522 |
| 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 | THI Medikal Sanayi Ticaret A.S, THI TOTAL HEALTHCARE INNOVATION GMBH |
| Establishment registrations | 3017300722, 3031572397 |
| FEI numbers | 3017300722, 3031572397 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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