FDA device listing
Pentips,Unifine Pentips,Unifine Pentips Plus
FDA device listing 1311341826 · OWEN MUMFORD LTD.
Key facts
| Proprietary names | Pentips,Unifine Pentips,Unifine Pentips Plus |
|---|---|
| Owner/operator | OWEN MUMFORD LTD. |
| Owner/operator number | 8021764 |
| Premarket submissions | K152339 |
| 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 | Owen Mumford Limited, OWEN MUMFORD USA, INC. |
| Establishment registrations | 1058602, 3003348846 |
| FEI numbers | 1000219614, 3003348846 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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