BD Safety-Lok
SYR Safetylok 10ML LL W/NDL 21X1-1/2 TW
71manufacturers in China registered for this device type
15catalogue numbers in this listing
12510(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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K944757 |
| Record published | 2016-09-19 |
| Record revised | 2025-08-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry; Special storage condition: Fragile, handle with care |
| Packaging | Case of 8, case of 10, pack or inner pack of 50, case of 5, pack or inner pack of 100 |
| Sizes | Length 0.625 to 1.5 in; needle gauge 22 to 25 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 305564 | 50 | In distribution | |
| 305902 | Length 1 in | In distribution | |
| 309593 | 100 | In distribution | |
| 305561 | 50 | In distribution | |
| 309606 | 100 | In distribution | |
| 309594 | 100 | In distribution | |
| 309596 | 100 | In distribution | |
| 305554 | In distribution | ||
| 305901 | Length 0.625 in | In distribution | |
| 305558 | 50 | In distribution | |
| 309595 | 100 | In distribution | |
| 305559 | 50 | In distribution | |
| 305900 | Needle Gauge 22 G | In distribution | |
| 305553 | In distribution | ||
| 309592 | 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 |
| 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 |
|---|---|
| K223286 | 2022-12-28 |
| K213478 | 2022-06-28 |
| K213156 | 2021-12-08 |
| K212015 | 2021-11-19 |
| K181730 | 2019-03-01 |
| K182320 | 2018-12-20 |
| K170824 | 2018-08-20 |
| K162516 | 2016-12-09 |
| K161553 | 2016-07-06 |
| K161170 | 2016-05-27 |
| K110703 | 2011-07-27 |
| K100005 | 2010-04-15 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2020-07-28 | Class II | Equipment maintenance | Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines. | 125,200 units | 2021-04-23 |
| Becton, Dickinson & Co. | 510(k) number | 2019-02-01 | Class II | Under Investigation by firm | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. | 428,800 | 2020-06-11 |
| Centurion Medical Products, LP | 510(k) number | 2017-07-05 | Class II | Material/Component Contamination | Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD’s recall due to pa | 2018-03-09 | |
| Becton, Dickinson & Co. | 510(k) number | 2017-06-13 | Class II | Process control | Presence of loose polypropylene foreign matter above release specification. | 1,249,200 units | 2020-06-22 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 29,500 units | 2018-03-20 |
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.