InterActive®Surgical Kit Mini Empty: 1 catalogue number listed by Implant Direct Sybron Manufacturing LLC, 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 InterActive®Surgical Kit Mini Empty | Listed by | Implant Direct Sybron Manufacturing LLC, 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 | Repacker / relabeller, Manufacturer |
| 510(k) | K200858 |
| Record published | 2021-03-01 |
| Record revised | 2023-04-04 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
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.