SmartClip
Soft Tissue Marker and Delivery System - PINK (Revised Frequency)
1manufacturer
37catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Elucent Medical Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K180640 |
| Record published | 2018-07-17 |
| Record revised | 2023-09-18 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 55 °C |
| Distribution end date | 2023-02-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SMARTCLIP LITE, GREEN, 7.5CM | 10 | In distribution | |
| SMARTCLIPLT-GRN-7.5 | 10 | In distribution | |
| SMARTCLIP LITE, PURPLE, 5CM | 10 | In distribution | |
| SMARTCLIPLT-PINK-10 | 10 | In distribution | |
| SMARTCLIP LITE, GREEN, 5CM | 10 | In distribution | |
| SMARTCLIP LITE, PINK, 10CM | 10 | In distribution | |
| SMARTCLIPLT-GRN-5 | 10 | In distribution | |
| SMARTCLIPLT-YLW-10 | 10 | In distribution | |
| SMARTCLIPLT-PURP-5 | 10 | In distribution | |
| SMARTCLIPLT-GRN-10 | 10 | In distribution | |
| SMARTCLIPLT-PURP-10 | 10 | In distribution | |
| SMARTCLIP LITE, PINK, 7.5CM | 10 | In distribution | |
| SMARTCLIP LITE, PURPLE, 10CM | 10 | In distribution | |
| SMARTCLIP LITE, GREEN, 10CM | 10 | In distribution | |
| SMARTCLIPLT-PNK-7.5 | 10 | In distribution | |
| SMARTCLIPLT-YLW-5 | 10 | In distribution | |
| SMARTCLIPLT-PINK-5 | 10 | In distribution | |
| SMARTCLIPLT-PURP-7.5 | 10 | In distribution | |
| SMARTCLIPLT-VLT-10 | 10 | In distribution | |
| SMARTCLIPLT-VLT-7.5 | 10 | In distribution | |
| SMARTCLIPLT-VLT-5 | 10 | In distribution | |
| SMARTCLIPLT-YLW-7.5 | 10 | In distribution | |
| SMARTCLIP LITE, PURPLE, 7.5CM | 10 | In distribution | |
| SMARTCLIP LITE, PINK, 5CM | 10 | In distribution | |
| SMARTCLIP-GRN-10 | 10 | Withdrawn | |
| SMARTCLIP-PINK-10 | 10 | Withdrawn | |
| SMARTCLIP LITE, PURPLE, 5CM | 10 | Withdrawn | |
| SMARTCLIP-PURP-10 | 10 | Withdrawn | |
| SMARTCLIP LITE, GREEN, 7.5CM | 10 | Withdrawn | |
| SMARTCLIP LITE, PURPLE, 10CM | 10 | Withdrawn | |
| SMARTCLIP LITE, PURPLE, 7.5CM | 10 | Withdrawn | |
| SMARTCLIP LITE, PINK, 7.5CM | 10 | Withdrawn | |
| SMARTCLIP LITE, PINK, 10CM | 10 | Withdrawn | |
| SMARTCLIP LITE, PINK, 5CM | 10 | Withdrawn | |
| SMARTCLIP-PINK-10 | 10 | Withdrawn | |
| SMARTCLIP LITE, GREEN, 5CM | 10 | Withdrawn | |
| SMARTCLIP LITE, GREEN, 10CM | 10 | 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 |
| 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 |
| Mammotome revolve MammoMark | Devicor Medical Products, Inc. | 10 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233639 | 2024-12-20 |
| K183400 | 2019-03-22 |
| K180640 | 2018-06-04 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2024-11-18 | Class II | Device Design | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. | 283 (48 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.