FDA device listing
TechLITE Pen Needle
FDA device listing 2043990582 · ARKRAY FACTORY USA, Inc.
Key facts
| Proprietary names | TechLITE Pen Needle |
|---|---|
| Owner/operator | ARKRAY FACTORY USA, Inc. |
| Owner/operator number | 8030316 |
| Premarket submissions | K210059 |
| Product codes | FMI |
| Device names | FMI - Needle, Hypodermic, Single Lumen |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5570 |
| Review panels | General Hospital |
| Registered establishments | ARKRAY FACTORY USA, INC. |
| Establishment registrations | 1832816 |
| FEI numbers | 1832816 |
| Establishment operations | Complaint File Establishment |
| 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