Duns Number:080935429
Device Description: Lead Wires;D-3A1120 DIN to Snap, White
Catalog Number
31244422A
Brand Name
Kendall
Version/Model Number
31244422A
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
-
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
K942321,K942321
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
2c7c3a84-4161-49ba-811c-e52da2e8eeb0
Public Version Date
January 03, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521148390
Quantity per Package
25
Contains DI Package
20884521148397
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 |