Duns Number:421256891
Device Description: Electrophysiology Catheter
Catalog Number
F6004005115FRT
Brand Name
NA
Version/Model Number
F6004005115FRT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
-
Product Code
DRF
Product Code Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Public Device Record Key
380e9554-ebc8-4fd1-8d75-23d8e8674818
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 15, 2016
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. | 35 |