FDA device listing
Amplatz Renal Dilator Set,Amplatz Sheath,Fascial Dilator,Renal Dilator,Renal Dilator with Amplatz Sheath
FDA device listing 1411928461 · ALLWIN MEDICAL DEVICES, INC.
Key facts
| Proprietary names | Amplatz Renal Dilator Set,Amplatz Sheath,Fascial Dilator,Renal Dilator,Renal Dilator with Amplatz Sheath |
|---|---|
| Owner/operator | ALLWIN MEDICAL DEVICES, INC. |
| Owner/operator number | 9094082 |
| Product codes | GCC |
| Device names | GCC - Dilator, Catheter |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ALLWIN MEDICAL DEVICES, INC. |
| Establishment registrations | 3005987240 |
| FEI numbers | 3005987240 |
| 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