Maci Implantation; Surgical Implantation; Vericel Surgical Implantation: 1 catalogue number listed by Vericel Corporation, United States, under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Maci Implantation; Surgical Implantation; Vericel Surgical Implantation | Listed by | Vericel Corporation, United States |
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K171520 |
| Record published | 2022-07-15 |
| Record revised | 2023-08-10 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial 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.