FDA device listing
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use,easyEndoTM Universal Linear Cutting Stapler and…
FDA device listing 1699308853 · Lucky Star lrradiation Science Co.,Ltd Shanghai
Key facts
| Proprietary names | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use,easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use |
|---|---|
| Owner/operator | Lucky Star lrradiation Science Co.,Ltd Shanghai |
| Owner/operator number | 10085638 |
| Product codes | GDW |
| Device names | GDW - Staple, Implantable |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4750 |
| Review panels | General & Plastic Surgery |
| Registered establishments | LUCKY STAR LRRADIATION SCIENCE CO.,LTD SHANGHAI |
| Establishment registrations | 3009848807 |
| FEI numbers | 3009848807 |
| Establishment operations | Contract Sterilizer |
| 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