Rochester
SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M MULTILEAD LEADWIRE, (5-LEAD), COLOR GROUP T5 10 Sets/Box
4manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | LifeSync Corporation, United States |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
| Record revised | 2026-05-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NC-852650 | In distribution | ||
| NS-S81015-A-24SC | 24 | In distribution | |
| NC-852637 | In distribution | ||
| NS-S82025-PT3-20SC | 20 | In distribution | |
| NS-S86025-T1-10SC | 10 | In distribution | |
| NS-S81915-A-24SC | 24 | In distribution | |
| NS-S85025-T5-10SC | 10 | In distribution | |
| NC-852375 | In distribution | ||
| NS-S94015-A-24SC | 24 | In distribution | |
| NC-852725 | In distribution | ||
| NS-S86015-T1-10SC | In distribution | ||
| NC-853025 | In distribution | ||
| NS-S91625-A-24SC | 24 | In distribution | |
| NS-S81025-A-24SC | 24 | In distribution | |
| NS-S82015-PT3-20SC | 20 | In distribution | |
| NS-S91615-A-24SC | 24 | In distribution | |
| NS-S85015-T5-10SC | 10 | In distribution | |
| NS-S94025-A-24SC | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
Showing 12 of 106. All products under Electrode, Needle
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.