Duns Number:052758618
Device Description: The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is 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.
Catalog Number
00355
Brand Name
Vashe Sterile Sleeve
Version/Model Number
00355
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMW
Product Code Name
Drape, Microscope, Ophthalmic
Public Device Record Key
ef0eb1a7-b6c2-483f-9966-2edcdfc2ecc5
Public Version Date
December 08, 2021
Public Version Number
4
DI Record Publish Date
July 17, 2017
Package DI Number
10190769003552
Quantity per Package
12
Contains DI Package
00190769003555
Package Discontinue Date
December 07, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |