FDA device listing
18G x 14.9cm (5.875 inch) Chiba Needle,18G x 14.9cm (5.875 inch) Chiba Needle with AccuMark Sheath,18G x 14.9cm (5.875…
FDA device listing 1338522141 · INRAD
Key facts
| Proprietary names | 18G x 14.9cm (5.875 inch) Chiba Needle,18G x 14.9cm (5.875 inch) Chiba Needle with AccuMark Sheath,18G x 14.9cm (5.875 inch) SampleMaster Chiba Needle,18G x 14.9cm (5.875 inch) SampleMaster Chiba Needle with HiLiter Tip,18G x 20.0cm (7.875 inch) Chiba Needle,18G x 20.0cm (7.875 inch) Chiba Needle with AccuMark Sheath,18G x 20.0cm (7.875 inch) Franseen Needle,18G x 6.0cm (2.350 inch) SampleMaster… |
|---|---|
| Owner/operator | INRAD |
| Owner/operator number | 9031756 |
| Premarket submissions | K813368 |
| 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 | RLS Interventional Inc. DBA Inrad |
| Establishment registrations | 1835568 |
| FEI numbers | 3001237677 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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