Duns Number:201637158
Device Description: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and mi GluSeal®90 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
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,K083752
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
0e7d2b83-eef1-427c-b5d4-83036cb88eac
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 07, 2017
Package DI Number
D795133
Quantity per Package
12
Contains DI Package
D795130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |