Duns Number:315620229
Catalog Number
107622
Brand Name
EFH-25
Version/Model Number
107622
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2022
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
126b5097-2e06-411a-9d86-1f2309dcbc92
Public Version Date
October 06, 2022
Public Version Number
4
DI Record Publish Date
August 19, 2014
Package DI Number
04035479000769
Quantity per Package
10
Contains DI Package
04035479144852
Package Discontinue Date
October 05, 2022
Package Status
Not 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 |