Duns Number:080935429
Device Description: Standard Porous Tape
Catalog Number
6613C
Brand Name
Kendall
Version/Model Number
6613C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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)
Yes
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
83d06143-1487-471e-8f97-1f9891da56ac
Public Version Date
June 11, 2021
Public Version Number
4
DI Record Publish Date
June 29, 2018
Package DI Number
20884521138893
Quantity per Package
72
Contains DI Package
10884521138896
Package Discontinue Date
July 01, 2023
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |