Duns Number:080935429
Device Description: DL Disposable Cable and Lead Wire System, 5 Lead Dual Connect, Adapter Required
Catalog Number
33135TG
Brand Name
Kendall
Version/Model Number
33135TG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
54e1a615-e7d8-45ca-ae46-9e011e7243c7
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 20, 2018
Package DI Number
30884521621491
Quantity per Package
50
Contains DI Package
10884521621497
Package Discontinue Date
-
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 |