Prevention
A reusable high level disinfectant solution designed to be used with heat sensitive medical devices and instruments, for which heat sterilization is not suitable.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Virox Technologies, Inc., Canada |
|---|---|
| FDA product code | MED |
| Device type | Sterilant, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6885 |
| Establishment | Manufacturer |
| 510(k) | K091022 |
| Record published | 2017-08-01 |
| Record revised | 2023-04-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 0 to 65 % RH; Handling environment temperature 15 to 30 °C; Special storage condition: Keep in original container |
| Packaging | Case of 4 |
| Sizes | Total volume 4 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HLD8 High Level Disinfectant | Total Volume 4 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterilant, Medical Devices | Steris Corporation | 149 |
| Formed Irrigating Cystotomes | Sterimedix Ltd. | 37 |
| Hydrodissection Cannulae | Sterimedix Ltd. | 29 |
| Sterilant, Medical Devices | Corporation Steris Canada | 29 |
| Anterior Chamber Maintenance Cannulae | Sterimedix Ltd. | 17 |
| Anaesthetic Needles | Sterimedix Ltd. | 14 |
| Formed Capsularhexis Cystotomes | Sterimedix Ltd. | 8 |
| Refractive Cannulae | Sterimedix Ltd. | 8 |
| enspire | Corporation Steris Canada | 8 |
| Cidex™ | Advanced Sterilization Products Services Inc. | 8 |
| Bimanual Cannulae and Hand Pieces | Sterimedix Ltd. | 7 |
| Bimanual I/A Systems | Sterimedix Ltd. | 7 |
Showing 12 of 96. All products under Sterilant, Medical Devices
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.