5 catalogue numbers from DC05-10, listed by Surgical Design, Inc., United States, under Curette, Surgical, General Use. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Royal TEK | Listed by | Surgical Design, Inc., United States |
| FDA product code | FZS |
| Device type | Curette, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2026-04-10 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 68 to 72 °F |
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.