Catalogue number 1100-508, listed by Sontec Instruments, Inc., United States, under Saw, Manual And Accessories. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Gigli SAW Solid Handle | Listed by | Sontec Instruments, Inc., United States |
| FDA product code | GDR |
| Device type | Saw, Manual And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2026-03-05 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| 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.