FDA device listing
OneMark Breast Localization Marker,OneMark Detection Imaging System,OneMark Detector Console,OneMark DIS Console & Probe…
FDA device listing 1786429168 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | OneMark Breast Localization Marker,OneMark Detection Imaging System,OneMark Detector Console,OneMark DIS Console & Probe Activities: Manufacturer,OneMark DIS Probe 01 |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Premarket submissions | K241762 |
| Product codes | NEU |
| Device names | NEU - Marker, Radiographic, Implantable |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4300 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MERIT MEDICAL SYSTEMS, INC., VIEW POINT MEDICAL, INC. |
| Establishment registrations | 1721504, 3021179744 |
| FEI numbers | 1721504, 3021179744 |
| Establishment operations | Complaint File Establishment, 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