Duns Number:106295384
Device Description: Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
Catalog Number
-
Brand Name
INGEVITY™ MRI
Version/Model Number
7742
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P150012,P150012,P150012,P150012,P150012,P150012
Product Code
NVN
Product Code Name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Public Device Record Key
a28e80f0-3c4e-475b-96e2-ee13c3c3496e
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
May 10, 2016
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 |