Duns Number:080935429
Device Description: DL Disposable Lead Set,5 Lead Dual Connect
Catalog Number
33136K
Brand Name
Kendall
Version/Model Number
33136K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 10, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
841d2d7a-972e-40d6-8fae-d1b75f2a3314
Public Version Date
April 24, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521083995
Quantity per Package
100
Contains DI Package
10884521083998
Package Discontinue Date
April 10, 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 |