STERiJECT TM
TSK STERiJECT Premium Disposable Hypodermic Needle
71manufacturers in China registered for this device type
140catalogue 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 | TSK Laboratory, Japan, Japan |
|---|---|
| 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) | K970370 |
| Record published | 2024-06-10 |
| Record revised | 2019-10-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 2, pack of 60, carton of 60, pack of 10, carton of 20 |
| Sizes | Outer diameter 0.2 to 1.8 mm; length 4 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HPC-29013E | Outer Diameter 0.33 mm | 2,000 | In distribution |
| PRE-32004 | Length 4 mm | 100 | In distribution |
| PRE-30006 | Outer Diameter 0.3 mm | 100 | In distribution |
| PRC22050ICSH | Outer Diameter 0.7 mm | 25 | In distribution |
| PRE-31013 | Outer Diameter 0.25 mm | 100 | In distribution |
| PRE-25013I | Outer Diameter 0.5 mm | 100 | In distribution |
| PRC25050ICSH | Length 50 mm | 25 | In distribution |
| PRE-30004 | Length 4 mm | 100 | In distribution |
| HPC-29010E | Outer Diameter 0.33 mm | 1,600 | In distribution |
| LDS-33009 | Length 9 mm | 100 | In distribution |
| PRC25038ICSH | Outer Diameter 0.5 mm | 25 | In distribution |
| PRC-30025ISG | Length 25 mm | In distribution | |
| LDS-30009I | Outer Diameter 0.3 mm | 2,000 | In distribution |
| PRC22038ICSH | Length 38 mm | 25 | In distribution |
| PRC-22070ISG | Outer Diameter 0.7 mm | In distribution | |
| HPC-23013I | Length 13 mm | 320 | In distribution |
| PRC-27050ISG | Length 50 mm | In distribution | |
| PRE-25050 | Length 50 mm | 100 | In distribution |
| PRE-30006I | Outer Diameter 0.3 mm | 100 | In distribution |
| PRC-27013I | Length 13 mm | 100 | In distribution |
| PRE-32009 | Length 9 mm | 100 | In distribution |
| HPC-32013A | Outer Diameter 0.26 mm | 4 | In distribution |
| PRE-30025 | Length 25 mm | 100 | In distribution |
| LDS-32009 | Length 9 mm | 100 | In distribution |
| HPC-27013I | Outer Diameter 0.4 mm | 100 | In distribution |
| PRE-30004I | Length 4 mm | 100 | In distribution |
| LDS-27006I | Outer Diameter 0.4 mm | 100 | In distribution |
| LDS-33013 | Length 13 mm | 100 | In distribution |
| HPC-23013I | Length 13 mm | 2,000 | In distribution |
| PRC27025ICSH | Length 25 mm | 25 | In distribution |
| PRC-25038ISG | Outer Diameter 0.5 mm | In distribution | |
| PRE-32013NP | Outer Diameter 0.23 mm | 100 | In distribution |
| HPC-27019I | Length 19 mm | 320 | In distribution |
| PRC-22050I | Length 50 mm | 100 | In distribution |
| PRC-25013I | Outer Diameter 0.5 mm | 2,000 | In distribution |
| PRE-25013I | Outer Diameter 0.5 mm | 2,000 | In distribution |
| HPC-27013A | Length 13 mm | 4 | In distribution |
| PRE-30006 | Length 6 mm | 100 | In distribution |
| PRE-27013N | Outer Diameter 0.4 mm | 100 | In distribution |
| HPC-30013I | Outer Diameter 0.3 mm | 2,000 | In distribution |
| HPC-29010E | Outer Diameter 0.33 mm | 320 | In distribution |
| PRE-21025SH | Outer Diameter 0.8 mm | In distribution | |
| HPC-30013E | Outer Diameter 0.3 mm | 320 | In distribution |
| PRE-32009 | Outer Diameter 0.26 mm | 100 | In distribution |
| PRC27038ICSH | Length 38 mm | 25 | In distribution |
| PRC-25013I | Outer Diameter 0.5 mm | 100 | In distribution |
| PRE-27013N | Outer Diameter 0.4 mm | 100 | In distribution |
| PRC-25050ISG | Length 50 mm | In distribution | |
| PRE-27006 | Length 6 mm | 100 | In distribution |
| HPC-27013I | Outer Diameter 0.4 mm | 1,600 | In distribution |
| PRC27050ICSH | Outer Diameter 0.4 mm | 25 | In distribution |
| LDS-32009 | Outer Diameter 0.26 mm | 1,600 | In distribution |
| LDS-25025 | Outer Diameter 0.5 mm | 100 | In distribution |
| HPC-31013E | Outer Diameter 0.25 mm | 320 | In distribution |
| PRE-32013N | Outer Diameter 0.26 mm | 100 | In distribution |
| PRE-22100 | Length 100 mm | 100 | In distribution |
| PRC27038ICSH | Outer Diameter 0.4 mm | 100 | In distribution |
| HPC-30013A | Length 13 mm | 50 | In distribution |
| PRC-30013IN | Length 13 mm | 100 | In distribution |
| HPC-25025A | Length 25 mm | 4 | In distribution |
| LDS-33013 | Length 13 mm | 2,000 | In distribution |
| PRE-31013 | Length 13 mm | 100 | In distribution |
| PRE-27013SH | Length 13 mm | In distribution | |
| LDS-32013 | Length 13 mm | 1,600 | In distribution |
| HPC-30013I | Length 13 mm | 100 | In distribution |
| PRC27025ICSH | Outer Diameter 0.4 mm | 100 | In distribution |
| PRC-27025ISG | Outer Diameter 0.4 mm | In distribution | |
| HPC-30013E | Length 13 mm | 2,000 | In distribution |
| PRE-15080 | Length 80 mm | 100 | In distribution |
| PRC30025ICSH | Length 25 mm | 25 | In distribution |
| PRC25038ICSH | Outer Diameter 0.5 mm | 100 | In distribution |
| LDS-33009 | Length 9 mm | 2,000 | In distribution |
| PRC25050ICSH | Length 50 mm | 100 | In distribution |
| HPC-27013A | Outer Diameter 0.4 mm | 50 | In distribution |
| LDS-30013I | Outer Diameter 0.3 mm | 100 | In distribution |
| HPC-29010E | Outer Diameter 0.33 mm | 100 | In distribution |
| PRE-32013 | Outer Diameter 0.26 mm | 320 | In distribution |
| PRC-22050ISG | Length 50 mm | In distribution | |
| PRE-32013 | Length 13 mm | 100 | In distribution |
| PRE-30013I | Length 13 mm | 100 | In distribution |
| PRC-27038I | Length 38 mm | 100 | In distribution |
| PRE-23019 | Outer Diameter 0.6 mm | 100 | In distribution |
| PRE-32013P | Outer Diameter 0.23 mm | 100 | In distribution |
| HPC-31013E | Length 13 mm | 100 | In distribution |
| PRE-23019SH | Length 19 mm | In distribution | |
| PRC-27038ISG | Outer Diameter 0.4 mm | In distribution | |
| HPC-23013I | Outer Diameter 0.6 mm | 100 | In distribution |
| HPC-29010E | Outer Diameter 0.33 mm | 2,000 | In distribution |
| PRC-27019I | Length 19 mm | 100 | In distribution |
| LDS-32013 | Outer Diameter 0.26 mm | 100 | In distribution |
| HPC-30013I | Outer Diameter 0.3 mm | 1,600 | In distribution |
| PRC-30013I | Length 13 mm | 100 | In distribution |
| HPC-27013I | Outer Diameter 0.4 mm | 2,000 | In distribution |
| PRE-30013I | Length 13 mm | 320 | In distribution |
| LDS-02009 | Outer Diameter 0.2 mm | 2,000 | In distribution |
| LDS-30013I | Length 13 mm | 2,000 | In distribution |
| HPC-27019I | Length 19 mm | 100 | In distribution |
| HPC-32013A | Length 13 mm | 50 | In distribution |
| PRC-27013I | Length 13 mm | 320 | In distribution |
| PRE-32006 | Outer Diameter 0.26 mm | 100 | In distribution |
| HPC-31013E | Length 13 mm | 2,000 | In distribution |
| HPC-30013I | Length 13 mm | 320 | In distribution |
| PRC30019ICSH | Outer Diameter 0.3 mm | 25 | In distribution |
| PRC-30013I | Outer Diameter 0.3 mm | 100 | In distribution |
| PRE-22070 | Length 70 mm | 100 | In distribution |
| HPC-30013E | Length 13 mm | 100 | In distribution |
| PRE-30004 | Length 4 mm | 100 | In distribution |
| LDS-02009 | Outer Diameter 0.2 mm | 100 | In distribution |
| PRC-30013I | Outer Diameter 0.3 mm | 320 | In distribution |
| LDS-25025T | Length 25 mm | 100 | In distribution |
| PRE-32013N | Length 13 mm | 100 | In distribution |
| HPC-31013E | Length 13 mm | 1,600 | In distribution |
| HPC-29013E | Length 13 mm | 100 | In distribution |
| PRC-27013I | Length 13 mm | 2,000 | In distribution |
| PRE-32013 | Length 13 mm | 100 | In distribution |
| HPC-29013E | Outer Diameter 0.33 mm | 320 | In distribution |
| PRC22070ICSH | Length 70 mm | 25 | In distribution |
| LDS-30013I | Outer Diameter 0.3 mm | 1,600 | In distribution |
| PRE-27006 | Length 6 mm | 100 | In distribution |
| PRC-27025I | Length 25 mm | 100 | In distribution |
| PRE-32009P | Outer Diameter 0.23 mm | 100 | In distribution |
| PRC-30013I | Outer Diameter 0.3 mm | 2,000 | In distribution |
| PRC-25013I | Outer Diameter 0.5 mm | 320 | In distribution |
| LDS-30009I | Length 9 mm | 100 | In distribution |
| HPC-27019I | Outer Diameter 0.4 mm | 2,000 | In distribution |
| HPC-27013I | Outer Diameter 0.4 mm | 320 | In distribution |
| PRE-33013 | Length 13 mm | 320 | In distribution |
| HPC-30013E | Outer Diameter 0.3 mm | 1,600 | In distribution |
| HPC-25025A | Outer Diameter 0.5 mm | 50 | In distribution |
| PRC-19038I | Outer Diameter 1.1 mm | 100 | In distribution |
| HPC-29013E | Length 13 mm | 1,600 | In distribution |
| HPC-30013A | Outer Diameter 0.3 mm | 4 | In distribution |
| PRE-31013 | Outer Diameter 0.28 mm | 320 | In distribution |
| PRE-33013 | Length 13 mm | 100 | In distribution |
| PRE-27013IP | Length 13 mm | 100 | In distribution |
| PRE-25013SH | Outer Diameter 0.5 mm | In distribution | |
| PRE-30025 | Outer Diameter 0.3 mm | 100 | In distribution |
| PRE-32004 | Length 4 mm | 100 | In distribution |
| PRE-33004 | Outer Diameter 0.24 mm | 100 | In distribution |
| PRE-31013P | Outer Diameter 0.25 mm | 100 | 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 |
| 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 |
| Needle, Hypodermic, Single Lumen | Becton, Dickinson AND Company | 76 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250284 | 2025-07-24 |
| K970370 | 1997-04-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merz North America, Inc. | 510(k) number | 2011-12-16 | Not classified | Packaging process control | Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 m | 5 boxes (20 units per box) | 2012-07-27 |
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.