FDA device listing
Nipple Guard
FDA device listing 1970328171 · SHONEY SCIENTIFIC, INC.
Key facts
| Proprietary names | Nipple Guard |
|---|---|
| Owner/operator | SHONEY SCIENTIFIC, INC. |
| Owner/operator number | 2183650 |
| Product codes | GBI |
| Device names | GBI - Material, External Aesthetic Restoration, Used With Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.3800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SHONEY SCIENTIFIC, INC. |
| Establishment registrations | 2183650 |
| FEI numbers | 2183650 |
| Establishment operations | Repackager/Relabeler |
| 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