FDA device listing
Saljet Single Dose Sterile Saline
FDA device listing 1083109070 · WINCHESTER LABORATORIES, LLLP
Key facts
| Proprietary names | Saljet Single Dose Sterile Saline |
|---|---|
| Owner/operator | WINCHESTER LABORATORIES, LLLP |
| Owner/operator number | 9041041 |
| Premarket submissions | K993969 |
| Product codes | FRO |
| Device names | FRO - Dressing, Wound, Drug |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO |
| Review panels | General & Plastic Surgery |
| Registered establishments | WINCHESTER LABORATORIES, LLLP |
| Establishment registrations | 1424524 |
| FEI numbers | 3003036307 |
| Establishment operations | 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