TopFine®
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and…
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.
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 | Medexel Co., Ltd., South Korea |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K152410 |
| Record published | 2019-02-23 |
| Record revised | 2019-10-23 (version 3) |
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 |
| Storage | Storage environment temperature 1 to 30 °C |
| Packaging | Case of 12, master case of 6 |
| Sizes | Length 4 to 12.7 mm; needle gauge 29 to 34 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TopFine®Insulin Pen Needles 31Gx4mm 100pcs | Length 4 mm | In distribution |
| TopFine®Insulin Pen Needles 34Gx5mm 100pcs | Length 5 mm | In distribution |
| TopFine®Insulin Pen Needles 30Gx8mm 100pcs | Length 8 mm | In distribution |
| TopFine Insulin Pen Needles 31Gx6mm 100pcs | Length 6 mm | In distribution |
| TopFine®Insulin Pen Needles 31Gx10mm 100pcs | Length 10 mm | In distribution |
| TopFine®Insulin Pen Needles 33Gx4mm 100pcs | Length 4 mm | In distribution |
| TopFine®Insulin Pen Needles 31Gx8mm 100pcs | Length 8 mm | In distribution |
| TopFine®Insulin Pen Needles 32Gx5mm 100pcs | Length 5 mm | In distribution |
| TopFine®Insulin Pen Needles 32Gx6mm 100pcs | Length 6 mm | In distribution |
| TopFine®Insulin Pen Needles 31Gx5mm 100pcs | Length 5 mm | In distribution |
| TopFine®Insulin Pen Needles 29Gx12.7mm 100pcs | Length 12.7 mm | In distribution |
| TopFine®Insulin Pen Needles 33Gx5mm 100pcs | Length 5 mm | In distribution |
| TopFine®Insulin Pen Needles 32Gx4mm 100pcs | Needle Gauge 32 G | In distribution |
| TopFine®Insulin Pen Needles 34Gx4mm 100pcs | Length 4 mm | 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 |
|---|---|
| K172095 | 2018-07-24 |
| K152410 | 2016-02-02 |
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.