Banicide Plus Sterilizing and Disinfecting Solution
Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallon Sterilization, high level disinfection and cleaning/decontamination solution.
1manufacturer
1catalogue number
1510(k) clearance
1recall
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 | Pascal International, Inc., United States |
|---|---|
| FDA product code | MED |
| Device type | Sterilant, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6885 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2019-01-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 59 to 86 °F |
| Packaging | Pallet of 144, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15200 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K012889 | 2003-05-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-08-09 | Not classified | Other | The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use. | 89,922 units (each unit is one gallon) | 2011-01-17 |
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.