Molli
MOLLI Introducer and MOLLI Marker (12 cm, 14GA) For use with the MOLLI System Note, the Introducer is MR Unsafe, however, the implantable Marker is MR conditional.
1manufacturer
7catalogue numbers in this listing
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K223107 |
| Record published | 2023-03-30 |
| Record revised | 2026-01-21 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide, Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Shelf carton of 10, pack of 10, case of 4 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MP2001 | In distribution | |
| MS-00009 | In distribution | |
| MT2001 | In distribution | |
| MP2015A | In distribution | |
| MM1000 | In distribution | |
| MP1001 | Withdrawn | |
| MT1001 | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Endoscopy | UDI-DI | 2026-01-21 | Class II | Under Investigation by firm | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures. | 5,864 |
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.