Duns Number:302846407
Device Description: ECG Electrodes
Catalog Number
SBW601
Brand Name
Stable Base
Version/Model Number
W-601
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"
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
c8c0f501-5bf8-44ca-bc1e-fb572a9d5426
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 17, 2015
Package DI Number
30861779000278
Quantity per Package
4
Contains DI Package
20861779000271
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |
3 | A medical device with high risk that requires premarket approval | 17 |