Duns Number:006261481
Device Description: LEAD 383074 MRI US
Catalog Number
-
Brand Name
SelectSecure™ MRI SureScan™
Version/Model Number
383074
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
P030036,P030036
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
6c7045d0-bbf8-4a07-8c26-a8ee5a9e087a
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 11, 2018
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 |