Duns Number:080935429
Device Description: Skin Barrier Wipe
Catalog Number
6560
Brand Name
Kendall
Version/Model Number
6560
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
5b2ed61b-6eb9-4e4b-b740-290e89f75746
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
June 30, 2018
Package DI Number
20884527020635
Quantity per Package
50
Contains DI Package
10884527020638
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |