FDA device listing
Silhouette Soft Suture SMS102,Silhouette Soft Suture SMS22,Silhouette Soft Suture SMS23,Silhouette Soft Suture…
FDA device listing 1493571952 · Vaupell Molding and Tooling, Inc.
Key facts
| Proprietary names | Silhouette Soft Suture SMS102,Silhouette Soft Suture SMS22,Silhouette Soft Suture SMS23,Silhouette Soft Suture SMS25,Silhouette Soft Suture SMS26 |
|---|---|
| Owner/operator | Vaupell Molding and Tooling, Inc. |
| Owner/operator number | 10042966 |
| Product codes | GAM |
| Device names | GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4493 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Vaupell Midwest Molding and Tooling |
| Establishment registrations | 3003595343 |
| FEI numbers | 3003595343 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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