Duns Number:100439103
Device Description: Covidien - DL Disp. 3 Lead Cable and Lead Wire Sys
Catalog Number
-
Brand Name
Covidien ECG Leads
Version/Model Number
RM-33103
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
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
1de22e26-da2b-4e95-a714-47391ca0e750
Public Version Date
August 02, 2019
Public Version Number
3
DI Record Publish Date
August 23, 2016
Package DI Number
10816317020573
Quantity per Package
10
Contains DI Package
00816317020576
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 | 68 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |