Catalog Number

525-028

Brand Name

STRADIS

Version/Model Number

525-028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 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

K780126,K780126

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

8735a5d1-ad69-467d-a3fe-6d13b446f5c3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 15, 2016

Package DI Number

M7525250282

Quantity per Package

10

Contains DI Package

M7525250281

Package Discontinue Date

June 15, 2016

Package Status

Not in Commercial Distribution

Package Type

BOX