Med-Dyne
PRE-Wired Hydro GEL Electrode, Large Socket - 24" Long Lead Wire - SET OF 4 (2 Black / 2 White) - Pack OF 40 Total
22manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 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 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Dongguan Rongrui-Century Science&Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Palconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Redy-MED Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)
Record
| Listed by | MED-Dyne, United States |
|---|---|
| FDA product code | DSA |
| Device type | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2900 |
| Establishment | Manufacturer |
| 510(k) | K080112 |
| Record published | 2016-09-24 |
| Record revised | 2024-06-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 24 to 60 in; lumen/inner diameter 24 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G24AL | Length 24 in | In distribution |
| G60AS | Length 60 in | In distribution |
| GE84 | Length 24 in | In distribution |
| GE84-40 | Length 24 in | In distribution |
| R24AS2 | Length 24 in | In distribution |
| GL4024-40 | Length 24 in | In distribution |
| R24AL | Length 24 in | In distribution |
| R24AD | Length 24 in | In distribution |
| R24DS | Length 24 in | In distribution |
| R24CD | Length 24 in | In distribution |
| R24AS | Length 24 in | In distribution |
| R24CL | Length 24 in | In distribution |
| G536L | Length 36 in | In distribution |
| G24AS | Length 24 in | In distribution |
| R24AR | Length 24 in | In distribution |
| G536S | Length 36 in | In distribution |
| GL7024-30 | Length 24 in | In distribution |
| G4830-30 | In distribution | |
| R24CS | Length 24 in | In distribution |
| R24CR | Lumen/Inner Diameter 24 in | In distribution |
| G24AR-30 | Length 24 in | In distribution |
| G48AS | Length 48 in | In distribution |
| GE84-60 | Length 24 in | In distribution |
| G24BS | Length 24 in | In distribution |
| G24AR | Length 24 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 5,928 |
| AMC | LifeSync Corporation | 1,058 |
| Fogg System Company, Inc. | Fogg System Company, Inc. | 693 |
| Multi-Link™ | AirLife Finland Oy | 611 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | ConMed Corporation | 284 |
| Maguire | Maguire Enterprises, Inc. | 193 |
| MediChoice | Owens & Minor Distribution, Inc. | 160 |
| Vermed | Graphic Controls Acquisition Corporation | 159 |
| Vital Signs™ | AirLife Finland Oy | 136 |
| Multi-Link™ | Carefusion Finland 320 Oy | 136 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 129 |
| Conmed | ConMed Corporation | 106 |
Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080112 | 2008-06-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Natus Medical Denmark ApS | 510(k) number | 2019-08-01 | Class II | Software design (manufacturing process) | The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. | 4,882 units (41950 individual electrode leads supplied In 5, |
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.