Atar D-Mdtl
Catalogue number ATAR D-MDTL, listed by Oscor Inc., United States, under Cable, Electrode. 47 manufacturers in China are registered for this product code.
47manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
2recalls on this code
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 | Oscor Inc., United States |
|---|---|
| FDA product code | IKD |
| Device type | Cable, Electrode |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1175 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070926 |
| Record published | 2017-10-03 |
| Record revised | 2026-02-04 (version 5) |
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, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Length 250 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ATAR D-MDTL | Length 250 cm | 5 | In distribution |
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 | Stryker Sustainability Solutions | 110 |
| Cable, Electrode | GE Healthcare Finland OY | 103 |
Showing 12 of 473. All products under Cable, Electrode
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070926 | 2007-06-07 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Oscor Inc. | 510(k) number | 2017-03-31 | Class I | Process control | The Reusable Oscor ATAR extension cables could separate from the connector during use. | 19,178 units | 2024-07-15 |
| Oscor Inc. | 510(k) number | 2017-03-31 | Class I | Process control | The Reusable Oscor ATAR extension cables could separate from the connector during use. | 36,242 units | 2024-07-15 |
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.