Duns Number:315620229
Catalog Number
115489
Brand Name
EFH-16
Version/Model Number
115489
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
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
a8c9ebc1-48a6-4484-ba36-14629f5c85df
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
August 14, 2014
Package DI Number
04035479002916
Quantity per Package
10
Contains DI Package
04035479144821
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |
| 3 | A medical device with high risk that requires premarket approval | 402 |