Grass® MR Conditional/CT Cup Electrodes
Grass MR Conditional/CT Cup Electrodes record surface physiological signals through cups placed on the skin. The range supports EEG and related recordings, with array configurations also…
Grass MR Conditional/CT Cup Electrodes record surface physiological signals through cups placed on the skin. The range supports EEG and related recordings, with array configurations also used for ECG, evoked potentials and polysomnography.
Conductive paste or gel couples the cup to the skin, and lead wires carry the signal to the recording equipment. Cups can be secured at the scalp or other recording sites.
Listed Item
Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1.5M
Electrodes and Extension Cables
The electrodes and arrays have MR-conditional and CT use conditions specified for the device. Included extension cables are MR/CT unsafe and have a different role and restriction from the electrode assembly. The electrodes are discarded after use.
Who Else Makes It
Concentrated in Guangdong (29), Jiangsu (4), Zhejiang (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Shenzhen Zifound Infonet Technology Co., Ltd. | Shenzhen, Guandong | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
Showing 12 of 47. All 47 manufacturers in China registered for Electrode, Cutaneous
Record
| Listed by | Natus Manufacturing Limited, Ireland |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K242346 |
| Record published | 2024-09-10 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MRARR27-39 | In distribution | |
| MRSIN3-59 | In distribution | |
| MRSIN3-39 | In distribution | |
| MRARR30-39 | In distribution | |
| MRSIN2-59 | In distribution | |
| MRARR27-59 | In distribution | |
| MRARR23-59 | In distribution | |
| MRSIN1-39 | In distribution | |
| MRARR23-39 | In distribution | |
| MRARR25-39 | In distribution | |
| MRSIN2-39 | In distribution | |
| MRARR30-59 | In distribution | |
| MRSIN1-59 | In distribution | |
| MRARR25-59 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 455 |
| waveguard | Eemagine Medical Imaging Solutions Gmbh | 166 |
| Espire Elbow Hybrid | College Park Industries | 138 |
| Technomed Europe | Technomed Engineering B.V. | 126 |
| Cadwell | Technomed Engineering B.V. | 111 |
| The Electrode Store | Impulse Technology LLC | 109 |
| Electrode, Cutaneous | Gmdasz Manufacturing Co., Ltd. | 99 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 93 |
| AdvanTrode | Pepin Manufacturing, Inc. | 78 |
| Uni-Patch | Cardinal Health | 77 |
| Alpha | WillowWood Global LLC | 68 |
| Espire Elbow Pro | College Park Industries | 67 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242346 | 2024-08-29 |
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.