Additional information
| Regulatory Compliance | N/A |
|---|---|
| Manufacturing Unit | Fully Compliant under ISO 13485:2016 QMS |
| Product Classification | Non- Class I Rule 1 |
| Biocompatibility | Tested and compliant with ISO 10993 series standards |
| Primary Material | Validated Medical Grade Wire |
| Secondary Material | Medical Grade Brass/Stainless Steel Terminals |
| Surface Finish | Smooth and Flexible |
| Safety Compliance | REACH and RoHS compliant |
| Manufacturing Environment | Assembled and packed in controlled environment |
| Reprocessing Status | Yes, it is Reusable Product. See IFU for reprocessing info |
| Reprocessing Method | Validated Steam Autoclave (121°C – 135°C, 3–5 min Holding Time) |
| Chemical Disinfection | CE-Certified validated agent suitable for Electrosurgical Instruments |
| EMDN Code | N/A |
| Packaging Unit | Individually packed (1 piece per unit) / 20 units per box |
| Minimum Order Quantity | 20 Pieces / 01 Box |
| Manufacturer | Electro Range MFG Co. – ERMC® |
