Duns Number:006261481
Device Description: LEAD 5086MRI52 US
Catalog Number
-
Brand Name
CapSureFix MRI™ SureScan™
Version/Model Number
5086MRI52
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 18, 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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P090013
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
20c8c32b-9efe-434e-a63d-b136698e9dc9
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
April 14, 2015
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 |