Duns Number:023904428
Device Description: Adhesive Remover 2.4"x2.4"
Catalog Number
-
Brand Name
MvKesson
Version/Model Number
176-5729
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"
Yes
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
8aa911c0-fa24-4ec4-8063-9ef78f967dc0
Public Version Date
April 01, 2019
Public Version Number
1
DI Record Publish Date
March 22, 2019
Package DI Number
00612479227958
Quantity per Package
200
Contains DI Package
00612479227941
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |