Duns Number:006261481
Device Description: ICD DVFC3D4 VISIA AF S VR DF4 MRI US
Catalog Number
-
Brand Name
Visia AF MRI™ S VR SureScan™
Version/Model Number
DVFC3D4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2019
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
2671f6a6-ee7f-4172-8e92-ec6f2c3c6288
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
August 13, 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 |