A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached
| Company | Devices | Share |
|---|---|---|
| Medax Srl Unipersonale | 31 | 39% |
| Izi Medical Products, Llc | 21 | 26% |
| Northern Digital Inc | 18 | 22% |
| Myco Medical Supplies Inc. | 4 | 5% |
| Microport Navibot International Llc | 2 | 2% |
| 7D Surgical Ulc | 2 | 2% |
| Smith & Nephew, Inc. | 1 | 1% |
| Compass International | 1 | 1% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| MIJ | Needle, Tumor Localization | 52 |
| HAW | Neurological Stereotaxic Instrument | 19 |
| OLO | Orthopedic Stereotaxic Instrument | 7 |
| KNW | Instrument, Biopsy | 4 |
| FCG | Biopsy Needle | 4 |
| OLO | Orthopedic stereotaxic instrument | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Imaging lesion localization marker, external, single-use", from 8 companies. The largest labeler is Medax Srl Unipersonale with 39% of records.
MIJ (Needle, Tumor Localization), HAW (Neurological Stereotaxic Instrument), OLO (Orthopedic Stereotaxic Instrument), KNW (Instrument, Biopsy)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.