Catalogue number PN0316, listed by Platts & Nisbett Limited, under Gouge, Surgical, General & Plastic Surgery. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Capener Lamina Gouge, Cranked, 240mm O/L, 6mm Width | Listed by | Platts & Nisbett Limited |
| FDA product code | GDH |
| Device type | Gouge, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2023-09-18 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
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.