McKesson
Solution, Glut+ 3.4% 28DAY QT
1manufacturer
7catalogue 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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | MED |
| Device type | Sterilant, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6885 |
| Record published | 2016-12-09 |
| Record revised | 2025-11-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 4, case of 16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 339 | In distribution | |
| 68-102800 | In distribution | |
| 343 | In distribution | |
| 68-101400 | In distribution | |
| 344 | In distribution | |
| 341 | In distribution | |
| 73-OPA28 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 28 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal |
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.