Curaplex
Curaplex OB Kit Poly Bagged with Umbilical Scissors
15manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Shanghai (3), Anhui (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Dongguan SafeSecure Plastics Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| S.E.S. Healthcare Products Co., Ltd. | Heifei | Anhui | Contract manufacturer | 5 |
| Shanghai Leyi Plastic Products Co Ltd | Shanghai | Shanghai | Contract manufacturer | 5 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
Showing 12 of 15. All 15 manufacturers in China registered for Cover, Barrier, Protective
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | MMP |
| Device type | Cover, Barrier, Protective |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-16 |
| Record revised | 2021-12-22 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Packaging | Case of 35, case of 16, case of 20, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2812-01927 | In distribution | |
| 4440010-B | In distribution | |
| 444001 | In distribution | |
| 2525-15022 | In distribution | |
| 444003 | In distribution | |
| 444004 | In distribution | |
| 444002 | In distribution | |
| 4440010 | In distribution | |
| 44200S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 63 |
| Medline | Medline Industries, Inc. | 27 |
| Medline Industries, Inc. | Medline Industries, Inc. | 24 |
| Patterson® | Patterson Dental Supply, Inc. | 11 |
| Equipment Cover Bag Type | Argon Medical Devices, Inc. | 8 |
| Cover, Barrier, Protective | Mavig Gmbh | 7 |
| Pinnacle X-Ray Sensor Sheaths | Metrex Research | 7 |
| Mizuho OSI | Maytex Corp. | 6 |
| Spectrum, Inc. | Spectrum Medical Ltd | 5 |
| Quala | National Distribution & Contracting Inc | 5 |
| Equipment Cover | Argon Medical Devices, Inc. | 5 |
| Equipment Cover Dome Type | Argon Medical Devices, Inc. | 5 |
Showing 12 of 97. All products under Cover, Barrier, Protective
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.