SMC Acupuncture Needle
SMC Acupuncture Needles are thin stainless-steel needles for skin penetration during acupuncture by qualified practitioners. The needle body is 304 stainless steel with a…
SMC Acupuncture Needles are thin stainless-steel needles for skin penetration during acupuncture by qualified practitioners. The needle body is 304 stainless steel with a polydimethylsiloxane coating.
The range includes different needle and tube lengths to suit the selected configuration. Needle diameters span 0.16 to 0.70 mm and lengths span 15 to 135 mm.
Listed Item
SMC acupuncture needle 0.18*15 (1,000pcs/Box) 20mm Handle SMC’s sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality.
Sterile Formats
Tube lengths range from 30 to 160 mm. Packaging configurations use gamma irradiation and/or ethylene oxide for sterilization. The needle, guide-tube dimensions and sterile packaging format are selected as part of the product configuration.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (3), Tianjin (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Hengxiang IMP. & EXP. Co., Ltd. | Suzhou | Jiangsu | Exporter | 35 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou | Jiangsu | Remanufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Hangzhou Goals Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Guangzhou Ahead Intelligent Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Wuxi Jiajian Medical Instrument Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Needle, Acupuncture, Single Use
Record
| Listed by | SMC, LLC., United States |
|---|---|
| FDA product code | MQX |
| Device type | Needle, Acupuncture, Single Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5580 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K141473 |
| Record published | 2017-05-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01603025 | 0.16*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 02205025 | 0.22*50 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 01801520 | 0.18*15 (1,000pcs/Box) 20mm Handle | 1,000 | In distribution |
| 02506025 | 0.25*60 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 03006025 | 0.30*60 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 02204025 | 0.22*40 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02203025 | 0.22*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02003025 | 0.20*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02001520 | 0.20*15 (100pcs/Box) 20mm Handle | 100 | In distribution |
| 02004025 | 0.20*40 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 01601520 | 0.16*15 (500pcs/Box) 20mm Handle | 500 | In distribution |
| 02003025 | 0.20*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 02803025 | 0.28*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 02004025 | 0.20*40 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01603025 | 0.16*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 01804025 | 0.18*40 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02506025 | 0.25*60 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 02503025 | 0.25*30 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01800813 | 0.18*08 (200pcs/Box) 13mm Handle | 200 | In distribution |
| 02503025 | 0.25*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02201520 | 0.22*15 (1,000pcs/Box) 20mm Handle | 1,000 | In distribution |
| 02503025 | 0.25*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 02505025 | 0.25*50 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01603025 | 0.16*30 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 03006025 | 0.30*60 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02505025 | 0.25*50 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 03003025 | 0.30*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 01803025 | 0.18*30 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02005025 | 0.20*50 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02504025 | 0.25*40 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01803025 | 0.18*30 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 02504025 | 0.25*40 (100pcs/Box) 25mm Handle | 100 | In distribution |
| 02203025 | 0.22*30 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01601520 | 0.16*15 (100pcs/Box) 20mm Handle | 100 | In distribution |
| 01804025 | 0.18*40 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 02504025 | 0.25*40 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 02001520 | 0.20*15 (1,000pcs/Box) 20mm handle | 1,000 | In distribution |
| 02201520 | 0.22*15 (100pcs/Box) 20mm Handle | 100 | In distribution |
| 01601520 | 0.16*15 (1,000pcs/Box) 20mm Handle | 1,000 | In distribution |
| 02204025 | 0.22*40 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 02203025 | 0.22*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 03004025 | 0.30*40 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 01803025 | 0.18*30 (500pcs/Box) 25mm Handle | 500 | In distribution |
| 01607013 | 0.16*07 (200pcs/Box) 13mm Handle | 200 | In distribution |
| 02003025 | 0.20*30 (1,000pcs/Box) 25mm Handle | 1,000 | In distribution |
| 03004025 | 0.30*40 (100pcs/Box) 25mm Handle | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Acupuncture Needles FOR Single USE | Changchun AIK Medical Devices Co., Ltd. | 397 |
| Seirin Acupuncture Needle | Seirin Corporation | 218 |
| Tewa | Asia-MED Gmbh | 186 |
| Tewa | asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG | 184 |
| Eacu, Eaku, Zagu, Jocu | Maanshan Bond Medical Instruments Co., Ltd. | 176 |
| AcuZone | Wujiang City ShenLing Medical Device Co., Ltd. | 158 |
| Lekon | C.A.I. Industries Corp. | 129 |
| TCMzoneHuaTuo | Tcmzone, LLC | 129 |
| Carbo | Wujiang City Cloud & Dragon Medical Device Co., Ltd. | 115 |
| Carbo | Wujiang City ShenLing Medical Device Co., Ltd. | 114 |
| ACE | Wuxi Jiajian Medical Instrument Co., Ltd. | 113 |
| Silverstar | Health Body World Supply Inc. | 101 |
Showing 12 of 184. All products under Needle, Acupuncture, Single Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141473 | 2014-08-01 |
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.