Duns Number:514996339
Catalog Number
SWDK 2030
Brand Name
Vcare Alpha
Version/Model Number
Wound Dressing Kit 20x30
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MKY
Product Code Name
System, Skin Closure
Public Device Record Key
76c244f1-f29a-40b2-90fd-4545fc74d83c
Public Version Date
November 23, 2021
Public Version Number
3
DI Record Publish Date
August 13, 2017
Package DI Number
17290111491303
Quantity per Package
20
Contains DI Package
07290111491306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Distribution Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |