Neutral PAD
Neutral PAD, Small Disposable, (25PCS)
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | ODR |
| Device type | Electrosurgical Patient Return Electrode |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123366 |
| Record published | 2016-09-21 |
| Record revised | 2023-01-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IEC-NPD-S | 25 | In distribution | |
| IEC-NPD1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Patient Dispersive Pad | Gynex Corporation | 2 |
| Cameron-Miller | Cameron-Miller, Inc. | 1 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 1 |
| Extra-Large Grounding PAD, 25 PCS | Cynosure, LLC | 1 |
| Patient Dispercive Pad | Gynex Corporation | 1 |
| IEC Neutral PAD | Cynosure, LLC | 1 |
| IEC Neutral Plate | Cynosure, LLC | 1 |
| Extra-Large Grounding PAD | Cynosure, LLC | 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.