Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
33523
Brand Name
Kendall
Version/Model Number
33523
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 29, 2020
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
2a5b6b3b-c4da-4212-8e81-cca2bb5ad3a4
Public Version Date
March 02, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
10884527021581
Quantity per Package
100
Contains DI Package
20884527021588
Package Discontinue Date
February 29, 2020
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 |