Leap Med
Disposable Needle Guide Kit
32manufacturers in China registered for this device type
14catalogue 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 | Advance Medical Designs, Inc., United States |
|---|---|
| FDA product code | GDF |
| Device type | Guide, Needle, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-TPU168 | In distribution | |
| 28-GG570 | In distribution | |
| 28-GG302 | In distribution | |
| 28-GG540 | In distribution | |
| 28-GG519PC | In distribution | |
| 28-GG554 | In distribution | |
| 28-TPU166 | In distribution | |
| 28-TPUA170 | In distribution | |
| 28-GG308 | In distribution | |
| 28-TPUA172 | In distribution | |
| 28-GG309 | In distribution | |
| 28-GG304 | In distribution | |
| 28-GG300 | In distribution | |
| 28-TPU167 | 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 |
| Gimmi | Gimmi Gmbh | 11 |
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 |
|---|---|---|---|---|
| 2023-07-07 | Class II | Other | Ultrasound gel mislabeled with inappropriate use. | 460 units |
| 2023-07-07 | Class II | Other | Ultrasound gel mislabeled with inappropriate use. | 1880 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.