Daniels
MW32 Pharmasmart Access Plus Container
18manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
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 | Daniels Corporation International PTY Ltd, Australia |
|---|---|
| FDA product code | MMK |
| Device type | Container, Sharps |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K001337 |
| Record published | 2019-09-13 |
| Record revised | 2023-08-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2019-06-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001107516 | In distribution | |
| 1001207500 | In distribution | |
| 1001307516 | In distribution | |
| 1003103501 | In distribution | |
| 1001201520 | In distribution | |
| 6403103501 | In distribution | |
| 1001207516 | In distribution | |
| 1003203501 | In distribution | |
| 1003307505 | In distribution | |
| 6403107503 | In distribution | |
| 1003303501 | In distribution | |
| 6403610508 | In distribution | |
| 1003307516 | In distribution | |
| 1001307500 | In distribution | |
| 1001107504 | In distribution | |
| 1003207505 | In distribution | |
| 6403007516 | In distribution | |
| 1001207504 | In distribution | |
| 1001107500 | In distribution | |
| 1003107505 | In distribution | |
| 1001307504 | In distribution | |
| 1001110523 | Withdrawn | |
| 1003110522 | Withdrawn | |
| 6403303510 | 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 |
| Oak Ridge Products | Oakridge Products, LLC | 21 |
| Curaplex | Bound Tree Medical, LLC | 20 |
| Bemis | Bemis de México, S.A. de C.V. | 20 |
Showing 12 of 96. All products under Container, Sharps
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091736 | 2009-10-30 |
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.