Duns Number:790268031
Device Description: Pacing Lead
Catalog Number
1688TC-58
Brand Name
Tendril™
Version/Model Number
SDX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
P960013
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
b3ceda9c-c1c7-49a8-ae34-114d0928fe54
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
February 03, 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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |