SureLead
42 catalogue numbers from DLSDR31M, listed by Authentic Medical, United States, under Cable, Transducer And Electrode, Patient, (Including Connector). 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
42catalogue 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 | Authentic Medical, United States |
|---|---|
| FDA product code | DSA |
| Device type | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2900 |
| Premarket notification | Exempt |
| Record published | 2018-03-06 |
| Record revised | 2024-06-06 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2019-05-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DLSDR31M | In distribution | |
| DLSDR51M | In distribution | |
| DLSNK31M | In distribution | |
| DLSMRT54F | In distribution | |
| DLSGE53M | In distribution | |
| DLSPHP5VL4F | In distribution | |
| DLSGGE31M | In distribution | |
| DLSGDRN31M | In distribution | |
| DLSGNK61M | In distribution | |
| DLSGPHP3L4F | In distribution | |
| DLSPHP6L4F | In distribution | |
| DLSGGE51M | In distribution | |
| DLSGPHP5L4F | In distribution | |
| DLSGPHP5PL13F | In distribution | |
| DLSWA51M1 | In distribution | |
| DLSGPHP5VL4F | In distribution | |
| DLSGGE53M | In distribution | |
| DLSGNK31M | In distribution | |
| DLSGE4VL1M | In distribution | |
| DLSPHP3L4F1 | In distribution | |
| DLSGPHP5P11F | In distribution | |
| DLSPHP12L4F | In distribution | |
| DLSPHP5L4F | In distribution | |
| DLSGGE5PL3M | In distribution | |
| DLSGE5PL3M | In distribution | |
| DLSGGE5VL1M | In distribution | |
| DLSGGE5VL3M | In distribution | |
| DLSGGE61M | In distribution | |
| DLSWA31M | In distribution | |
| DLSGDR31M | In distribution | |
| DLSPHP5P11F1 | In distribution | |
| DLSGGE4VL1M | In distribution | |
| DLSGDRN51M | In distribution | |
| DLSPHP5PL13F | In distribution | |
| DLSNK61M | In distribution | |
| DLSGE31M | In distribution | |
| DLSGE61M | In distribution | |
| DLSGMRT54F | In distribution | |
| DLSGE51M | In distribution | |
| DLSGE5VL3M | In distribution | |
| DLSGE5VL1M | In distribution | |
| TCMXAS10C | Withdrawn |
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 |
|---|---|
| K181089 | 2020-01-17 |
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.