Duns Number:052758618
Device Description: Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debride Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 250 ml (8.5 fl oz)) size with an instillation cap.
Catalog Number
00316
Brand Name
Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container
Version/Model Number
00316
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131848,K131848
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
94de0463-c29a-4f53-b47c-dbdd7710e7f7
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
February 07, 2020
Package DI Number
10851383003167
Quantity per Package
12
Contains DI Package
00851383003160
Package Discontinue Date
-
Package Status
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 |