Empira™ NC RX PTCA Dilatation Catheter - Empira™ NC RX PTCA Dilatation Catheter - TACTX MEDICAL, INC.

Duns Number:363487070

Device Description: Empira™ NC RX PTCA Dilatation Catheter

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More Product Details

Catalog Number

75R15200N

Brand Name

Empira™ NC RX PTCA Dilatation Catheter

Version/Model Number

75R15200N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device Record Status

Public Device Record Key

9202e345-0208-400c-b767-9df050c911da

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TACTX MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 133