FDA device listing
Decompression Needle
FDA device listing 2027031053 · Anping Guardian Medical Equipment Co.,Ltd
Key facts
| Proprietary names | Decompression Needle |
|---|---|
| Owner/operator | Anping Guardian Medical Equipment Co.,Ltd |
| Owner/operator number | 10088234 |
| Product codes | GAA |
| Device names | GAA - Needle, Aspiration And Injection, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ANPING GUARDIAN MEDICAL EQUIPMENT CO.,LTD |
| Establishment registrations | 3027617478 |
| FEI numbers | 3027617478 |
| Establishment operations | Foreign Exporter, 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