The STERLINK plus with STERPACK plus sterilization is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal…
The STERLINK plus with STERPACK plus sterilization is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK plus can sterilize: 1.Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors 2.Medical devices with a single stainless-steel lumen with: – STERPACK plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter – STERLOAD: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Sterilink™ | Listed by | Plasmapp Co., Ltd., South Korea |
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K212200 |
| Record published | 2023-07-13 |
| Record revised | 2023-10-25 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 45 °C; Storage environment humidity up to 90 % RH |
| Distribution end date | 2023-07-13 |
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.