Catalog Number

405078

Brand Name

HydroSteer™

Version/Model Number

405078

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

55dcdad7-9b43-4c70-a4fb-a8ac0e313335

Public Version Date

September 21, 2020

Public Version Number

5

DI Record Publish Date

December 02, 2015

Package DI Number

15414734055168

Quantity per Package

5

Contains DI Package

05414734055161

Package Discontinue Date

June 29, 2018

Package Status

Not in Commercial Distribution

Package Type

-