DeRoyal
Prep PVP Paint SM Latex Safe 20C
8manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Anhui (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OJU |
| Device type | Skin Prep Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
| Record revised | 2021-07-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 160, case of 40, case of 25, case of 64, case of 26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5-18129-ACS | In distribution | |
| 50-10752 | In distribution | |
| 50-10752NG | In distribution | |
| 50-002 | In distribution | |
| 50-002M | In distribution | |
| 50-9973 | In distribution | |
| 50-11075 | In distribution | |
| 89-4140 | In distribution | |
| 50-002NG | In distribution | |
| 89-9060 | In distribution | |
| 89-10370 | In distribution | |
| 50-11075NG | In distribution | |
| 50-002-T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 693 |
| Cardinal Health | Cardinal Health 200, LLC | 508 |
| Centurion | Centurion Medical Products Corporation | 43 |
| Medical Action Industries | Medical Action Industries, Inc. | 26 |
| LSL Healthcare | Lsl Industries, Inc. | 19 |
| Medline | Medline Industries, Inc. | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Skin Prep Tray | Carefusion 2200, Inc. | 4 |
| ACS | American Contract Systems, Inc. | 4 |
| Medline | Centurion Medical Products Corporation | 3 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| MAI | Medical Action Industries, Inc. | 2 |
Showing 12 of 16. All products under Skin Prep Tray
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.