SOL-M™ Hypodermic Needle
Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin. 26g x 3/8" IDB Needle
71manufacturers in China registered for this device type
29catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Sol-Millennium Medical, Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112777 |
| Record published | 2016-09-16 |
| Record revised | 2026-02-09 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 100 |
| Sizes | Needle gauge 16 to 31 G; length 10 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 112315 | Needle Gauge 23 G | In distribution |
| 112506 | Needle Gauge 25 G | In distribution |
| 112705 | Needle Gauge 27 G | In distribution |
| 111615 | Needle Gauge 16 G | In distribution |
| 112010 | Length 25 mm | In distribution |
| 1123125 | Needle Gauge 23 G | In distribution |
| 112658 | Length 16 mm | In distribution |
| 112515 | Needle Gauge 25 G | In distribution |
| 112410 | Length 25 mm | In distribution |
| 112210 | Needle Gauge 22 G | In distribution |
| 112612 | Needle Gauge 26 G | In distribution |
| 112510 | Needle Gauge 25 G | In distribution |
| 1122125 | Needle Gauge 22 G | In distribution |
| 111915 | Needle Gauge 19 G | In distribution |
| 112110 | Length 25 mm | In distribution |
| 112905 | Needle Gauge 29 G | In distribution |
| 112115 | Length 40 mm | In distribution |
| 112638 | Needle Gauge 26 G | In distribution |
| 112334 | Length 20 mm | In distribution |
| 113005 | Needle Gauge 30 G | In distribution |
| 111810 | Needle Gauge 18 G | In distribution |
| 111815 | Length 40 mm | In distribution |
| 113112 | Length 12.5 mm | In distribution |
| 112310 | Needle Gauge 23 G | In distribution |
| 112015 | Needle Gauge 20 G | In distribution |
| 112215 | Needle Gauge 22 G | In distribution |
| 111910 | Length 25 mm | In distribution |
| 112734 | Needle Gauge 27 G | In distribution |
| 113010 | Needle Gauge 30 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182146 | 2018-12-03 |
| K123684 | 2013-05-08 |
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.