DuaLok™
DuaLok™ Breast Lesion Localization Wire, 20g x 10.7cm
32manufacturers in China registered for this device type
5catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (8), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Zhejiang Solong Electromechanical Limited | Pujiang | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Showing 12 of 32. All 32 manufacturers in China registered for Guide, Needle, Surgical
Record
| Listed by | Bard Peripheral Vascular, Inc., United States |
|---|---|
| FDA product code | GDF |
| Device type | Guide, Needle, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-13 |
| Record revised | 2023-09-25 (version 5) |
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 |
| Packaging | Case of 10 |
| Sizes | Needle gauge 20 G; length 3.7 to 13.7 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LW0057 | Needle Gauge 20 G | In distribution |
| LW0107 | Length 10.7 cm | In distribution |
| LW0137 | Length 13.7 cm | In distribution |
| LW0037 | Needle Gauge 20 G | In distribution |
| LW0077 | Needle Gauge 20 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Needle Holder | Koros U.S.A., Inc. | 175 |
| Stoma® | Storz AM Mark Gmbh | 63 |
| Aptus | Medartis Inc. | 62 |
| Philips | Philips Medical Systems Nederland B.V. | 31 |
| Temno | Carefusion 2200, Inc. | 31 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 23 |
| Silex Sacroiliac Joint Fusion System | Xtant Medical Holdings, Inc. | 20 |
| Biopsybell | Biopsybell SRL | 16 |
| Arterial Needle | Argon Medical Devices, Inc. | 14 |
| Ghiatas® | Bard Peripheral Vascular, Inc. | 14 |
| Sklar® | Sklar Corporation | 14 |
| Leap Med | Advance Medical Designs, Inc. | 14 |
Showing 12 of 169. All products under Guide, Needle, Surgical
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2017-03-28 | Class II | Other | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. | 570 units | 2017-06-29 |
| 2014-08-26 | Class II | Other | Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier. | 177,760 units | 2015-03-06 |
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.