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
GLUSEALPT
Brand Name
GluSeal®
Version/Model Number
GLUSEALPT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 24, 2022
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
c1d8b7d2-9cd0-4714-ac99-49da2d6ee680
Public Version Date
January 25, 2022
Public Version Number
4
DI Record Publish Date
July 28, 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 |