FDA device listing
HydroMark Breast Biopsy Site Marker
FDA device listing 1000855910 · Devicor Medical Products, Inc.
Key facts
| Proprietary names | HydroMark Breast Biopsy Site Marker |
|---|---|
| Owner/operator | Devicor Medical Products, Inc. |
| Owner/operator number | 10033297 |
| Premarket submissions | K212158 |
| 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 | Devicor Medical Products de Mexico S de RL de CV, DEVICOR MEDICAL PRODUCTS, INC., Devicor Medical Products, Inc. Warehouse/Distribution/Service Center |
| Establishment registrations | 3008492462, 3008992312, 3010339638 |
| FEI numbers | 3008492462, 3008992312, 3010339638 |
| Establishment operations | Manufacturer, Remanufacturer, Specification Developer |
| 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