FDA device listing
low profile short lens,low profile wrap around lens,short lens sterile,sterishield,steri-shield face guard,sterishield…
FDA device listing 1865637413 · SYNTECH, INT'L INC.
Key facts
| Proprietary names | low profile short lens,low profile wrap around lens,short lens sterile,sterishield,steri-shield face guard,sterishield head gear,sterishield wrap around lens,wrap around lens sterile |
|---|---|
| Owner/operator | SYNTECH, INT'L INC. |
| Owner/operator number | 2083467 |
| Premarket submissions | K881913 |
| Product codes | FXX |
| Device names | FXX - Mask, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SYNTECH, INT'L INC. |
| Establishment registrations | 3005142514 |
| FEI numbers | 3005142514 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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