FDA device listing
Autoject II
FDA device listing 1767475334 · OWEN MUMFORD LTD.
Key facts
| Proprietary names | Autoject II |
|---|---|
| Owner/operator | OWEN MUMFORD LTD. |
| Owner/operator number | 8021764 |
| Premarket submissions | K122837 |
| Product codes | KZH |
| Device names | KZH - Introducer, Syringe Needle |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6920 |
| Review panels | General Hospital |
| Registered establishments | Owen Mumford Limited, OWEN MUMFORD, LTD., Owen Mumford Sdn Bhd |
| Establishment registrations | 8021764, 3003348846, 3013143994 |
| FEI numbers | 3000191104, 3003348846, 3013143994 |
| Establishment operations | Complaint File Establishment, Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler |
| 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