Duns Number:363487070
Device Description: Empira™ NC RX PTCA Dilatation Catheter
Catalog Number
75R12350N
Brand Name
Empira™ NC RX PTCA Dilatation Catheter
Version/Model Number
75R12350N
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
LOX
Product Code Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Public Device Record Key
1873d876-01df-4895-891d-7f1ece77f50a
Public Version Date
October 07, 2019
Public Version Number
3
DI Record Publish Date
September 23, 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. | 133 |