Duns Number:080935429
Device Description: Hypoallergenic Silk Tape
Catalog Number
7138C
Brand Name
Kendall
Version/Model Number
7138C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2022
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
88f72e06-173f-4adb-ab9d-709664f3c787
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
June 28, 2018
Package DI Number
20884521158709
Quantity per Package
120
Contains DI Package
10884521158702
Package Discontinue Date
February 22, 2022
Package Status
Not 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 |