Cook
X-Reidy Breast Lesion Localization Needle
3manufacturers in China registered for this device type
5catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | MIJ |
| Device type | Needle, Tumor Localization |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2023-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G19589 | In distribution | |
| G19418 | In distribution | |
| G19380 | In distribution | |
| G19533 | In distribution | |
| G19617 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kopans | Cook Incorporated | 27 |
| Medwire | Medax Srl Unipersonale | 22 |
| Sinurep | Medax Srl Unipersonale | 9 |
| ALM SET | H.S. Hospital Service SPA | 6 |
| Tuflex | Somatex Medical Technologies GmbH | 4 |
| Breast Needle Locator | Remington Medical, Inc. | 4 |
| Q-Wire System | Somatex Medical Technologies GmbH | 3 |
| Tuloc Premium | Somatex Medical Technologies GmbH | 3 |
| Tuloc | Somatex Medical Technologies GmbH | 3 |
| Tuflex Premium | Somatex Medical Technologies GmbH | 3 |
| MRI Tuloc | Somatex Medical Technologies GmbH | 2 |
| Duo System Stereo | Somatex Medical Technologies GmbH | 2 |
Showing 12 of 37. All products under Needle, Tumor Localization
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 | Closed |
|---|---|---|---|---|---|
| 2016-01-08 | Class II | Process control | Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens i | 134 | 2017-03-23 |
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.