Duns Number:006261481
Device Description: ICD DVMB1D4 EVERA MRI VR XT DF4 US
Catalog Number
-
Brand Name
Evera MRI™ XT VR SureScan™
Version/Model Number
DVMB1D4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
3f1fd2a4-8a66-429a-9e9a-899dcbe41a97
Public Version Date
February 05, 2021
Public Version Number
4
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 |