NovoFine® Plus 32g
NovoFine Plus 32G needles are sterile, disposable needles for use with pen injector devices. They deliver drugs under the skin, including insulin, GLP-1 analogs and somatropin, and are…
NovoFine Plus 32G needles are sterile, disposable needles for use with pen injector devices. They deliver drugs under the skin, including insulin, GLP-1 analogs and somatropin, and are intended for one injection only.
The needle attaches to the pen by a screw connection while held within its outer cap. Removing the protective tab and then the outer and inner caps prepares the needle for use with the compatible injector.
Listed Item
NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
After Injection
After delivery, the needle is withdrawn from the skin, detached from the injection device and discarded according to applicable local requirements. Each subsequent injection requires a fresh disposable needle. Injection technique follows the pen injector instructions and healthcare professional guidance.
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 | Novo Nordisk Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Complaint-file establishment |
| 510(k) | K133738 |
| Record published | 2016-09-17 |
| Record revised | 2026-02-02 (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 |
| Packaging | Pack of 288, pack of 60 |
| Sizes | Length 4 mm; needle gauge 32 G |
| Distribution end date | 2017-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 185591 | Length 4 mm | 7 | In distribution |
| 185850 | Needle Gauge 32 G | 6 | In distribution |
| 185851 | Needle Gauge 32 G | 6 | In distribution |
| 185550 | Length 4 mm | 100 | In distribution |
| 185650 | Needle Gauge 32 G | 4 | In distribution |
| 185651 | Needle Gauge 32 G | 4 | Withdrawn |
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 |
|---|---|
| K231255 | 2023-08-25 |
| K210258 | 2021-06-23 |
| K202005 | 2020-12-19 |
| K173479 | 2018-01-17 |
| K133738 | 2014-05-21 |
| K093109 | 2010-06-18 |
| K090111 | 2010-02-01 |
| K062500 | 2006-11-21 |
| K053470 | 2005-12-21 |
| K050106 | 2005-03-30 |
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.