Cidex™
CIDEX™ Instrument tray System 381 mm x 594 mm x 141 mm
1manufacturer
8catalogue numbers in this listing
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 | Advanced Sterilization Products Services Inc. |
|---|---|
| FDA product code | MED |
| Device type | Sterilant, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6885 |
| 510(k) | K032959 |
| Record published | 2016-09-24 |
| Record revised | 2025-12-23 (version 14) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 4, case of 2 |
| Distribution end date | 2020-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20398 | In distribution | |
| 82076 | In distribution | |
| 20390 | In distribution | |
| 82027 | In distribution | |
| 82032 | In distribution | |
| 82010 | In distribution | |
| 82016 | In distribution | |
| 2266 | Withdrawn |
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 |
| Bimanual Cannulae and Hand Pieces | Sterimedix Ltd. | 7 |
| Bimanual I/A Systems | Sterimedix Ltd. | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
Showing 12 of 96. All products under Sterilant, Medical Devices
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Advanced Sterilization Products | 510(k) number | 2015-08-10 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection wi | 318,632 cases | 2016-05-20 |
| Advanced Sterilization Products | 510(k) number | 2012-06-01 | Class II | Process control | The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012. | 1,310,844 units | 2013-09-11 |
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.