Skin Prep Tray
Dry Gauze Preoperative Skin Prep Tray With Powder-Free Gloves
8manufacturers in China registered for this device type
4catalogue numbers in this listing
2recalls on this code
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 | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | OJU |
| Device type | Skin Prep Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-18 |
| Record revised | 2024-02-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
| Distribution end date | 2023-10-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4437 | Withdrawn | |
| 4420 | Withdrawn | |
| 4468 | Withdrawn | |
| 4461A | Withdrawn |
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 |
| DeRoyal | Deroyal Industries, Inc. | 13 |
| Medline | Medline Industries, Inc. | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-07 | Not classified | Packaging process control | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety haz | 38,440 trays | 2015-06-05 |
| 2012-02-07 | Not classified | Packaging process control | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety haz | 1,505,140 trays | 2015-06-05 |
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.