Duns Number:487972069
Device Description: Hydrosoluble Nail Lacquer is available in a 12 mL bottle with applicator brush.
Catalog Number
-
Brand Name
Genadur
Version/Model Number
2
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083087
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
e773c6ef-19bd-4ce5-afcb-4e29b9eabf57
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
October 31, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |