Duns Number:042763706
Device Description: ELECTRODE FOAM ROUND 2" DIA 30/BAG L/F
Catalog Number
0030430
Brand Name
ACE
Version/Model Number
0030430
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
a3fcc1fa-72cd-43d5-9a58-8c48c55bcea2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 20, 2017
Package DI Number
10614950008756
Quantity per Package
30
Contains DI Package
00614950008759
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |