Duns Number:201637158
Device Description: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and mino GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
Catalog Number
GLUSEAL5V
Brand Name
GluSeal®
Version/Model Number
GLUSEAL5V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030574
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
ab60c884-4209-43a7-b8a7-d951d3d118c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 07, 2017
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |