Duns Number:006261481
Device Description: LEAD 383069 SELECTSECURE US MRI
Catalog Number
-
Brand Name
SelectSecure™ MRI SureScan™
Version/Model Number
383069
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2021
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
0dc184e9-d2ec-4ab7-a3cb-9e79bdbbb1bd
Public Version Date
January 31, 2022
Public Version Number
6
DI Record Publish Date
May 21, 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 |