PDI® Electrode Prep Pad
Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Zhejiang Excellent United Medical Technology Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 24 |
| Zhejiang Banghaoning Medical Supplies Co., Ltd. | Yiwu | Zhejiang | Manufacturer | 19 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
Record
| Listed by | Professional Disposables International, Inc., United States |
|---|---|
| FDA product code | KOY |
| Device type | Degreaser, Skin, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4730 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-03 |
| Record revised | 2022-05-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Packaging | Box of 100 |
| Sizes | Width 1.2 in; length 2.6 in |
| Distribution end date | 2022-05-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B59800 | Width 1.2 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adhesive Tape Remover Pads | Sion Brands LLC | 2 |
| Sion Biotext Medical Ltd. | Sion Biotext Medical Ltd | 2 |
| SafePrep | Spes Medica Srl | 1 |
| Electrode Skin Prep Pads | Dynarex Corp. | 1 |
| Tech Stick | Spes Medica Srl | 1 |
| Adhesive Tape Remover Pads, For Professional and Hospital Use | Dynarex Corp. | 1 |
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.