Aptus
1.6 K-Wire,70mm,Olive20mm,NoThread,1/Pkg
32manufacturers in China registered for this device type
62catalogue numbers in this listing
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 | Medartis 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 | 2023-02-24 |
| Record revised | 2025-04-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A-5045.44/1 | In distribution | ||
| A-5045.22/1 | In distribution | ||
| A-5046.65/2S | 2 | In distribution | |
| A-5045.22/2S | 2 | In distribution | |
| A-5046.47/2S | 2 | In distribution | |
| A-5045.43/1 | In distribution | ||
| A-5045.42/2S | 2 | In distribution | |
| A-5046.63/2S | 2 | In distribution | |
| A-5046.67/2S | 2 | In distribution | |
| A-5045.61/1 | In distribution | ||
| A-5045.66/2S | 2 | In distribution | |
| A-5046.43/1 | In distribution | ||
| A-5045.42/1 | In distribution | ||
| A-5046.61/2S | 2 | In distribution | |
| A-5045.45/1 | In distribution | ||
| A-5046.11/2S | 2 | In distribution | |
| A-5046.45/1 | In distribution | ||
| A-5045.21/2S | 2 | In distribution | |
| A-5046.41/1 | In distribution | ||
| A-5046.42/2S | 2 | In distribution | |
| A-5045.41/2S | 2 | In distribution | |
| A-5045.62/1 | In distribution | ||
| A-5046.22/2S | 2 | In distribution | |
| A-5046.64/2S | 2 | In distribution | |
| A-5045.41/1 | In distribution | ||
| A-5046.22/1 | In distribution | ||
| A-5046.11/1 | In distribution | ||
| A-5046.47/1 | In distribution | ||
| A-5046.41/2S | 2 | In distribution | |
| A-5046.21/1 | In distribution | ||
| A-5042.21/2S | 2 | In distribution | |
| A-5045.47/1 | In distribution | ||
| A-5046.45/2S | 2 | In distribution | |
| A-5046.21/2S | 2 | In distribution | |
| A-5045.44/2S | 2 | In distribution | |
| A-5046.42/1 | In distribution | ||
| A-5045.63/2S | 2 | In distribution | |
| A-5045.67/1 | In distribution | ||
| A-5045.47/2S | 2 | In distribution | |
| A-5045.46/2S | 2 | In distribution | |
| A-5046.62/2S | 2 | In distribution | |
| A-5045.65/2S | 2 | In distribution | |
| A-5046.44/2S | 2 | In distribution | |
| A-5045.64/2S | 2 | In distribution | |
| A-5045.66/1 | In distribution | ||
| A-5045.64/1 | In distribution | ||
| A-5045.61/2S | 2 | In distribution | |
| A-5046.63/1 | In distribution | ||
| A-5046.46/2S | 2 | In distribution | |
| A-5046.46/1 | In distribution | ||
| A-5045.46/1 | In distribution | ||
| A-5046.62/1 | In distribution | ||
| A-5045.63/1 | In distribution | ||
| A-5045.67/2S | 2 | In distribution | |
| A-5045.43/2S | 2 | In distribution | |
| A-5046.44/1 | In distribution | ||
| A-5045.45/2S | 2 | In distribution | |
| A-5045.65/1 | In distribution | ||
| A-5045.21/1 | In distribution | ||
| A-5046.43/2S | 2 | In distribution | |
| A-5045.62/2S | 2 | In distribution | |
| A-5046.66/2S | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Needle Holder | Koros U.S.A., Inc. | 175 |
| Stoma® | Storz AM Mark Gmbh | 63 |
| 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 |
| Gimmi | Gimmi Gmbh | 11 |
Showing 12 of 169. All products under Guide, Needle, Surgical
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.