FDA device listing
Staple Anchoring Device
FDA device listing 1880030493 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | Staple Anchoring Device |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | GDT |
| Device names | GDT - Staple, Removable (Skin) |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4760 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3015859709 |
| FEI numbers | 3003737899, 3015859709 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Repackager/Relabeler, Specification Developer |
| 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