Catalogue number MINI-DS, listed by Cartiheal (2009) Ltd, under Instruments Designed For Press-Fit Osteochondral Implants. 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Agili-C Mini Disposable Toolset | Listed by | Cartiheal (2009) Ltd |
| FDA product code | QBO |
| Device type | Instruments Designed For Press-Fit Osteochondral Implants |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4505 |
| Premarket notification | Exempt |
| Record published | 2022-10-04 |
| Record revised | 2025-03-27 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
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.