Duns Number:079163089
Device Description: 0.67 OZ
Catalog Number
GG80148
Brand Name
GluGone Adhesive Remover, 0.67 oz.
Version/Model Number
GG80148
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KOX
Product Code Name
Solvent, Adhesive Tape
Public Device Record Key
9cf02d49-2716-43bb-998e-069c1398c9b8
Public Version Date
July 05, 2022
Public Version Number
1
DI Record Publish Date
June 27, 2022
Package DI Number
10854137001730
Quantity per Package
48
Contains DI Package
00854137001733
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |