Curaplex
Curaplex 300D Large ALS Bag, Royal Blue, w/3 Modules & Sharps Container, 22 in L x 14 in W x 11 in H
18manufacturers in China registered for this device type
20catalogue numbers in this listing
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 | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | MMK |
| Device type | Container, Sharps |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Manufacturer |
| 510(k) | K942054 |
| Record published | 2018-12-15 |
| Record revised | 2023-10-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12, case of 24, pack of 24, case of 10, pack of 10, pack of 72 |
| Sizes | Length 6.5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1860-08704 | In distribution | |
| 64250 | Length 6.5 in | In distribution |
| 1860-08710 | In distribution | |
| 1860-08786 | In distribution | |
| 1860-08705 | In distribution | |
| 12317 | In distribution | |
| 1860-08700 | In distribution | |
| 64250 | In distribution | |
| 12358 | In distribution | |
| 68101S | In distribution | |
| 1860-08782 | In distribution | |
| 12307 | In distribution | |
| 1860-08784 | In distribution | |
| 12356 | In distribution | |
| 1860-08708 | In distribution | |
| 1860-08702 | In distribution | |
| 1860-08783 | In distribution | |
| 1860-08706 | In distribution | |
| 8783 | In distribution | |
| 1860-08708BR | In distribution |
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 |
| Bemis | Bemis de México, S.A. de C.V. | 20 |
Showing 12 of 96. All products under Container, Sharps
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.