Catalog Number

405066

Brand Name

HydroSteer™

Version/Model Number

405066

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

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

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

cd19d06e-34a7-45d1-8faf-09aadc892025

Public Version Date

September 21, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

15414734055045

Quantity per Package

5

Contains DI Package

05414734055048

Package Discontinue Date

June 29, 2018

Package Status

Not in Commercial Distribution

Package Type

-