Maxcon Sharps Container
Disposable Sharps Container 8 gallon with hinge and rotary lid
18manufacturers in China registered for this device type
10catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (3), Shanghai (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Container, Sharps
Record
| Listed by | Ningbo Maxcon Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | MMK |
| Device type | Container, Sharps |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K180984 |
| Record published | 2021-08-03 |
| Record revised | 2023-08-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2024-02-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MA1352 | In distribution | ||
| MA1341 | In distribution | ||
| ME13121 | In distribution | ||
| ME1261 | In distribution | ||
| MA1412 | Withdrawn | ||
| MA1321 | Withdrawn | ||
| MA1421 | Withdrawn | ||
| MA1211 | 20 | Withdrawn | |
| MA1211 | Withdrawn | ||
| MA1422 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APmedical | ABM Italia SPA | 91 |
| Monoject | Cardinal Health | 62 |
| Vermed | Graphic Controls Acquisition Corporation | 52 |
| SharpSafety | Cardinal Health | 37 |
| Mauser Wiva 4 | Envirotain, LLC | 36 |
| Medegen Medical Products | Medegen Medical Products | 32 |
| SharpsTank | Rehrig Pacific Company | 29 |
| Medline | Medline Industries, Inc. | 27 |
| Monoject | Cardinal Health 200, LLC | 24 |
| Daniels | Daniels Corporation International PTY Ltd | 24 |
| Oak Ridge Products | Oakridge Products, LLC | 21 |
| Curaplex | Bound Tree Medical, LLC | 20 |
Showing 12 of 96. All products under Container, Sharps
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222906 | 2023-06-16 |
| K222905 | 2023-06-01 |
| K180983 | 2019-01-03 |
| K180984 | 2019-01-03 |
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.