The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and…
The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and storage. Does not include accessory caddy.
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 Benesta Sterilization Tray | Listed by | Caldera Medical, Inc., 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, Manufacturer |
| 510(k) | K193603 |
| Record published | 2022-08-03 |
| Record revised | 2023-04-04 (version 2) |
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, manufacturing date |
| Storage | Special storage condition: Store at room temperature in a clean, dry location |
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.