The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over…
The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip.
Who Else Makes It
All of them in Jiangsu.
Record
Regulatory record for Vashe Sterile Sleeve | Listed by | Urgo Medical North America, LLC, United States |
| FDA product code | HMW |
| Device type | Drape, Microscope, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-17 |
| Record revised | 2024-09-11 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12 |
| Distribution end date | 2021-12-07 |
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.