Catalog Number

75R10300N

Brand Name

Empira™ NC RX PTCA Dilatation Catheter

Version/Model Number

75R10300N

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

51a6765c-fa55-4345-af30-b9a3e25cf851

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

-