Duns Number:175899459
Device Description: REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
Catalog Number
RD128210
Brand Name
NA
Version/Model Number
RD128210
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"
-
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
MTD
Product Code Name
Catheter, intracardiac mapping, high-density array
Public Device Record Key
dfc13d3d-76fc-4484-bfb0-c88bf1bb157a
Public Version Date
October 20, 2021
Public Version Number
1
DI Record Publish Date
October 12, 2021
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 | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |