Duns Number:216344051
Device Description: Universal Adhesive Remover Wipe
Catalog Number
403100
Brand Name
REMOVE Wipes
Version/Model Number
403100
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
614bb819-0e86-461b-9791-fb0dcf99f3b5
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 11, 2020
Package DI Number
00040565115665
Quantity per Package
50
Contains DI Package
00040565111810
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 | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |