Catalog Number

111304

Brand Name

DISTAFLEX

Version/Model Number

111304-001

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

MCX

Product Code Name

Catheter, Coronary, Atherectomy

Public Device Record Key

95882333-9aaf-4d7d-8ef9-7fdf667fdd9b

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 07, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-