Duns Number:006261481
Device Description: ICD-DR DDBB1D1 EVERA XT US DF1
Catalog Number
-
Brand Name
Evera™ XT DR
Version/Model Number
DDBB1D1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2019
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
LWS
Product Code Name
Implantable cardioverter defibrillator (non-CRT)
Public Device Record Key
cfac120e-5685-473b-b370-98481d306e6b
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
May 22, 2017
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |