Duns Number:106295384
Device Description: Pacemaker
Catalog Number
-
Brand Name
ESSENTIO™ DR
Version/Model Number
L101
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
N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003,N970003
Product Code
LWP
Product Code Name
Implantable pulse generator, pacemaker (non-CRT)
Public Device Record Key
cb06965a-2a75-4ef6-97fe-ef02655cae84
Public Version Date
October 01, 2021
Public Version Number
8
DI Record Publish Date
November 11, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |