FDA device listing
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
FDA device listing 1319318100 · Natus Medical Incorporated
Key facts
| Proprietary names | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES |
|---|---|
| Owner/operator | Natus Medical Incorporated |
| Owner/operator number | 9004873 |
| Premarket submissions | K112034 |
| Product codes | IKT |
| Device names | IKT - Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.1385 |
| Review panels | Physical Medicine |
| Registered establishments | Natus Manufacturing Limited |
| Establishment registrations | 3005581270 |
| FEI numbers | 3005581270 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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