Catalogue number 302429-000, listed by Cadwell Industries, Inc., United States, under Electrode, Needle. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Cadwell Side-by-Side Bipolar Probe | Listed by | Cadwell Industries, Inc., United States |
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K103128 |
| Record published | 2016-09-05 |
| Record revised | 2024-01-09 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -10 to 50 °C |
| Packaging | Pack of 10 |
| Sizes | Length 90 mm |
| Distribution end date | 2024-01-01 |
| UDI direct marking | Exempt |
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.