Cable, Electrode
Ablation Cable from SMARTABLATE System to CELSIUS Catheter or CARTO XP System PIU (DS)
47manufacturers in China registered for this device type
110catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (31), Jiangsu (4), Shandong (3). 14 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 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 47. All 47 manufacturers in China registered for Cable, Electrode
Record
| Listed by | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | IKD |
| Device type | Cable, Electrode |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1175 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
| Record revised | 2024-06-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -29 to 60 °C |
| Packaging | Case of 10, pack of 10, case of 20, case of 25, pack of 5, case |
| Sizes | Length 3 to 13.5 ft; length 150 to 365 cm; length 50 in |
| Distribution end date | 2023-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | Length 5.0 ft | In distribution |
| N/A | In distribution | |
| 33125 | Length 3.0 ft | In distribution |
| N/A | Length 5.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| A-ENS-MAGEXT-CBL | Length 213.0 cm | In distribution |
| M004 6710 | Length 305.0 cm | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 6.0 ft | In distribution |
| M004PF41M434 | Length 300.0 cm | In distribution |
| N/A | Length 300.0 cm | In distribution |
| N/A | In distribution | |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| 33114 | Length 3.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | In distribution | |
| N/A | Length 10.0 ft | In distribution |
| 33133 | Length 3.0 ft | In distribution |
| 989803211171 | In distribution | |
| N/A | Length 300.0 cm | In distribution |
| D-ENS-INQ-Q-CBL | Length 365.0 cm | In distribution |
| LW-309DS50/5AT | Length 50.0 in | In distribution |
| N/A | Length 150.0 cm | In distribution |
| 33103 | Length 10.0 ft | In distribution |
| D-ENS-AVSE-5-CBL | Length 365.0 cm | In distribution |
| N/A | Length 3.5 ft | In distribution |
| N/A | Length 150.0 cm | In distribution |
| D-ENS-L/R-DDY-CBL | Length 365.0 cm | In distribution |
| D-ENS-SUP-D-CBL | Length 365.0 cm | In distribution |
| CEDTC100 | Length 8.2 ft | In distribution |
| N/A | In distribution | |
| D-ENS-SUP-H-CBL | Length 365.0 cm | In distribution |
| N/A | Length 150.0 cm | In distribution |
| D134402 | Length 10.0 ft | In distribution |
| N/A | Length 6.0 ft | In distribution |
| N/A | Length 3.0 ft | In distribution |
| N/A | Length 300.0 cm | In distribution |
| D128624 | Length 10.0 ft | In distribution |
| D-ENS-L/R-HOD-CBL | Length 365.0 cm | In distribution |
| N/A | Length 6.0 ft | In distribution |
| N/A | Length 6.0 ft | In distribution |
| N/A | Length 9.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 250.0 cm | In distribution |
| LW-309DS50/5A | Length 50.0 in | In distribution |
| 33135T | Length 12.0 ft | In distribution |
| D-ENS-SUP-Q-CBL | Length 365.0 cm | In distribution |
| N/A | Length 180.0 cm | In distribution |
| N/A | Length 13.5 ft | In distribution |
| N/A | Length 6.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| D-ENS-AVSE-6-CBL | Length 365.0 cm | In distribution |
| N/A | Length 180.0 cm | In distribution |
| N/A | Length 180.0 cm | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 5.0 ft | In distribution |
| D133701 | Length 10.0 ft | In distribution |
| 33112 | Length 3.0 ft | In distribution |
| 33132 | Length 3.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| 989803173141 | In distribution | |
| N/A | Length 10.0 ft | In distribution |
| D128622 | Length 10.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| PSCIC101 | Length 251.46 cm | In distribution |
| 33134 | Length 3.0 ft | In distribution |
| D-AVSE-CBL12 | Length 150.0 cm | In distribution |
| 33113 | Length 3.0 ft | In distribution |
| D-ENS-L/R-BQ-CBL | Length 365.0 cm | In distribution |
| N/A | Length 12.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| M004PF41M444 | Length 300.0 cm | In distribution |
| 33145T | Length 9.0 ft | In distribution |
| 989803145051 | In distribution | |
| A-FASE-CBL4 | Length 250.0 cm | In distribution |
| N/A | Length 250.0 cm | In distribution |
| AFR-00006 | Length 200.0 cm | In distribution |
| N/A | Length 250.0 cm | In distribution |
| N/A | Length 5.0 ft | In distribution |
| LW-341DS50/5A | Length 50.0 in | In distribution |
| 33126 | Length 3.0 ft | In distribution |
| M004RAUMBILICAL20 | Length 6.6 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 180.0 cm | In distribution |
| N/A | Length 10.0 ft | In distribution |
| D-ENS-SUP-DDY-CBL | Length 365.0 cm | In distribution |
| N/A | In distribution | |
| LW-309DS50/3A | Length 50.0 in | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 180.0 cm | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Length 250.0 cm | In distribution |
| D133703 | Length 10.0 ft | In distribution |
| N/A | Length 6.0 ft | In distribution |
| N/A | Length 10.0 ft | In distribution |
| N/A | Length 180.0 cm | In distribution |
| D-ENS-INQ-DD-CBL | Length 365.0 cm | In distribution |
| 989803192141 | In distribution | |
| N/A | Length 3.0 ft | In distribution |
| D-ENS-INQ-OD-CBL | Length 365.0 cm | In distribution |
| 33136T | Length 3.0 ft | In distribution |
| D-AVSE-CBL22 | Length 150.0 cm | In distribution |
| N/A | Length 300.0 cm | Withdrawn |
| N/A | Length 150.0 cm | Withdrawn |
| N/A | Length 250.0 cm | Withdrawn |
| N/A | Length 150.0 cm | Withdrawn |
| N/A | Length 300.0 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orantech | Orantech Inc. | 1,344 |
| APK | APK Technology Co., Ltd. | 1,081 |
| FMT | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 249 |
| Med-Dyne | MED-Dyne | 244 |
| Cable, Electrode | PMT Corp. | 219 |
| Kendall | Cardinal Health 200, LLC | 212 |
| Kendall | Cardinal Health | 183 |
| C.M.P. Cable | C.M.P. Canadian Medical Products Inc. | 154 |
| Cable, Electrode | Innovative Health, LLC. | 133 |
| Medline | Medline Industries, Inc. | 112 |
| Cable, Electrode | GE Healthcare Finland OY | 103 |
| Lightweight Cabrio Cable | AD-Tech Medical Instrument Corp. | 99 |
Showing 12 of 473. All products under Cable, Electrode
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions | UDI-DI | 2024-07-02 | Class II | Labeling mix-ups | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have bee | 38,850 |
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.