Duns Number:216344051
Device Description: Universal adhesive remover
Catalog Number
403379
Brand Name
REMOVE Adhesive Remover 220ml US
Version/Model Number
403379
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
-
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
9056fd13-cb21-46f6-9c59-c6e7e399d7b7
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
September 04, 2020
Package DI Number
30040565116915
Quantity per Package
12
Contains DI Package
00040565116914
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |