Duns Number:101835833
Catalog Number
-
Brand Name
TB
Version/Model Number
020013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 14, 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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K861403
Product Code
LDF
Product Code Name
Electrode, Pacemaker, Temporary
Public Device Record Key
795a61b6-af6f-469e-b34a-9455520dd148
Public Version Date
July 24, 2020
Public Version Number
5
DI Record Publish Date
October 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 592 |
3 | A medical device with high risk that requires premarket approval | 16 |