Catalogue number 1612, listed by Katalyst Surgical, LLC, 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 Titanium 45° Angled Curette, 12mm | Listed by | Katalyst Surgical, LLC, United States |
| FDA product code | FZS |
| Device type | Curette, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-14 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | 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.