Assi
Dispersive Wristlet (Grounding) For Polarmate II
2manufacturers in China registered for this device type
1catalogue number
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 | Accurate Surgical & Scientific Instruments Corp., United States |
|---|---|
| FDA product code | ODR |
| Device type | Electrosurgical Patient Return Electrode |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-25 |
| Record revised | 2020-06-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC2621 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Patient Dispersive Pad | Gynex Corporation | 2 |
| Neutral PAD | Cynosure, LLC | 2 |
| Cameron-Miller | Cameron-Miller, Inc. | 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.