Duns Number:825880623
Device Description: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and min GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor irritation of the the skin and help protect them from infection.
Catalog Number
GLUSEAL(ST)
Brand Name
GluSeal®90
Version/Model Number
GLUSEAL(ST)
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
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
K083752
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
1881bf2a-342d-4e83-8392-d63e27247e48
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 16, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |