Natus Neurology
Disposable Monopolar Needle, 25mmx27G (24) per PK
4manufacturers in China registered for this device type
27catalogue numbers in this listing
1recall
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 | Natus Neurology Incorporated, United States |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K111131 |
| Record published | 2016-09-15 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2026-04-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-902-DMG25-TP | In distribution | |
| S-902-DMF37-TP | In distribution | |
| S-902-DMG37-S | In distribution | |
| S-902-DMG75-S | In distribution | |
| S-019-476000 | In distribution | |
| S-019-475200 | In distribution | |
| S-019-475100 | In distribution | |
| S-902-DMF25-TP | In distribution | |
| S-902-DMF25-S | In distribution | |
| S-019-476300 | In distribution | |
| S-019-475800 | In distribution | |
| S-019-476200 | In distribution | |
| S-902-RLC-TP | In distribution | |
| S-902-DMF37-S | In distribution | |
| S-902-DMG37-TP | In distribution | |
| 019-474900 | In distribution | |
| S-902-DMG50-TP | In distribution | |
| S-019-475900 | In distribution | |
| S-019-476400 | In distribution | |
| S-019-475700 | In distribution | |
| S-902-DMG50-S | In distribution | |
| S-902-DMG25-S | In distribution | |
| S-902-DMG75-TP | In distribution | |
| S-019-476100 | In distribution | |
| S-019-474800 | In distribution | |
| S-019-475000 | In distribution | |
| S-019-474900 | Withdrawn |
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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-04-28 | Not classified | Other | The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a m | 53 boxes, 10 electrodes per pouch, 10 pouches per box | 2006-12-27 |
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.