FDA device listing
11 guage Bone Access Needles,Access needles,Co-axial Introducer Needles,Homer Breast Localization Needles,Microlite…
FDA device listing 1417775402 · ARGON MEDICAL DEVICES, INC
Key facts
| Proprietary names | 11 guage Bone Access Needles,Access needles,Co-axial Introducer Needles,Homer Breast Localization Needles,Microlite Disposable Suction Needle |
|---|---|
| Owner/operator | ARGON MEDICAL DEVICES, INC |
| Owner/operator number | 9059795 |
| 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 | ARGON MEDICAL DEVICES INC., ARGON MEDICAL DEVICES, INC. |
| Establishment registrations | 1417485, 1625425 |
| FEI numbers | 1417485, 1625425 |
| Establishment operations | Contract Manufacturer, 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