Duns Number:080214481
Device Description: Goo Gone adhesive remover
Catalog Number
-
Brand Name
Micro-Scientific Goo Gone Topical and Surface Adhesive Remover
Version/Model Number
PK
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)
-
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
c92d9a60-c499-4aff-9eb8-0c27b6610f4e
Public Version Date
September 01, 2022
Public Version Number
1
DI Record Publish Date
August 24, 2022
Package DI Number
10739470000124
Quantity per Package
12
Contains DI Package
00739470000127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |