FDA device listing
AnsCare LeniScar Silicone Stick,AnsCare Scar Reduction Silicone Gel C+
FDA device listing 1001127732 · BENQ MATERIALS CORPORATION
Key facts
| Proprietary names | AnsCare LeniScar Silicone Stick,AnsCare Scar Reduction Silicone Gel C+ |
|---|---|
| Owner/operator | BENQ MATERIALS CORPORATION |
| Owner/operator number | 10044989 |
| Product codes | MDA |
| Device names | MDA - Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BENQ MATERIALS CORPORATION |
| Establishment registrations | 3010256218 |
| FEI numbers | 3010256218 |
| Establishment operations | Manufacturer |
| 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