Duns Number:826176703
Device Description: 24" RED SNAP ECG LEAD WIRE - SET OF 50
Catalog Number
-
Brand Name
Med-Dyne
Version/Model Number
SRD24-50
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
01ee0841-007e-4f26-841d-f8172ac5bd12
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
00817497022503
Quantity per Package
50
Contains DI Package
00817497022503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SET
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 280 |