Sentimag
Probe checker for Sentimag Gen 3 Probe
1manufacturer
4catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Endomagnetics Ltd, United Kingdom |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-02-09 |
| Record revised | 2026-01-27 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Gen 3 | In distribution | |
| Gen 3 Probe | In distribution | |
| Gen 3 Footswitch | In distribution | |
| Gen 3 Probe Checker | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232865 | 2024-06-28 |
| K222832 | 2023-01-21 |
| K173587 | 2018-02-16 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-10-01 | Class II | Process control | Potential for contamination with cotton fibers. | 540 units |
| 2025-10-01 | Class II | Process control | Potential for contamination with cotton fibers. | 1,760 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.