BioZorb Marker
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
1manufacturer
6catalogue numbers in this listing
4510(k) clearances naming this product 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 | Focal Therapeutics, United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Record published | 2015-10-26 |
| Record revised | 2024-02-12 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature; Special storage condition: If temperature indicator has a black center, do not use product. |
| Sizes | Length 2 to 5 cm; width 2 to 4 cm |
| Distribution end date | 2021-04-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F0404 | Length 4 cm | Withdrawn |
| F0202 | Length 2 cm | Withdrawn |
| F0405 | Length 5 cm | Withdrawn |
| F0304 | Length 4 cm | Withdrawn |
| F0303 | Length 3 cm | Withdrawn |
| F0203 | Width 2 cm | Withdrawn |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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192371 | 2019-09-26 |
| K152070 | 2015-08-26 |
| K143484 | 2015-06-29 |
| K113202 | 2012-02-28 |
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.