Steelex
Steelex Elec 3/0 (2) 60CM HRT17/GS65V
3manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | B Braun Surgical SA |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| Record published | 2015-08-16 |
| Record revised | 2026-03-31 (version 13) |
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 |
| Storage | Storage environment temperature -20 to 30 °C |
| Packaging | Carton of 30 |
| Sizes | Length 60 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C0992054 | Length 60 cm | 36 | Withdrawn |
| C0992100 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0992097 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0992097 | Thread Material : stainless steel | 12 | Withdrawn |
| C0992062 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0992100 | 12 | Withdrawn | |
| C0992046 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0992070 | Length 60 cm | 36 | Withdrawn |
| C0992038 | Length 60 cm | 36 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E Medical Corporation | 109 |
| Myo/Wire | A & E Medical Corporation | 76 |
| TB | Oscor Inc. | 40 |
| Temporary Myocardial Heartwire | Oscor Inc. | 27 |
| Pacel™ | St. Jude Medical Cardiovascular Division | 16 |
| Ethicon | Ethicon, Inc. | 15 |
| Flexon | Covidien LP | 13 |
| Electrode, Pacemaker, Temporary | Medtronic, Inc. | 12 |
| Nbih™ Temporary Pacing Electrode Catheter | C.R. Bard, Inc. | 11 |
| Electrode, Pacemaker, Temporary | C.R. Bard, Inc. | 10 |
| Streamline™ | Medtronic, Inc. | 10 |
| Helios | Oscor Inc. | 8 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
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.