Catalog Number

525-029

Brand Name

STRADIS

Version/Model Number

525-029

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 04, 2016

Issuing Agency

In HIBCC

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

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

6baf62a2-d6bd-4b64-8ef2-a5999f33f53a

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

May 04, 2016

Package DI Number

M7525250292

Quantity per Package

10

Contains DI Package

M7525250291

Package Discontinue Date

May 04, 2016

Package Status

Not in Commercial Distribution

Package Type

BOX