Monoject
Curved Tip Syringe 12mL
22manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (9), Shanghai (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Ningbo Caremed Medical Products Co Ltd | Ningbo | Zhejiang | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Shanghai Dynamic Medical Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 37 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
Showing 12 of 22. All 22 manufacturers in China registered for Syringe, Irrigating (Dental)
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | EIB |
| Device type | Syringe, Irrigating (Dental) |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Total volume 12 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8881412012 | Total Volume 12 ml | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipack | Unipack LLC | 15 |
| PlastCare | Proguard Health Inc. | 7 |
| Britedent | Bright Supply Inc | 7 |
| House Brand | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 4 |
| House brand | Shifeng Medical Technology Co.，ltd. | 3 |
| Safco Irrigating Syringes | Safco Dental Supply | 3 |
| House Brand Dentistry | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 3 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 3 |
| Nivo | B. ALI Impex | 1 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 1 |
| BR Surgical, LLC | BR Surgical LLC | 1 |
| Safco Air/Water Syringe Tips | Safco Dental Supply | 1 |
Showing 12 of 14. All products under Syringe, Irrigating (Dental)
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.